High-Intensity Treadmill Training for Multiple Sclerosis
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Marquette University
Must not be taking: Corticosteroids, Botulinum toxin
Disqualifiers: Uncontrolled hypertension, Diabetes, Cardiovascular disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial aims to help people with mild to moderate multiple sclerosis walk better by having them exercise intensely and practice balancing on a shaky treadmill. The combination of these activities is expected to improve their walking speed, endurance, and balance.
Will I have to stop taking my current medications?
The trial requires that your MS medications remain stable for at least 1 month before joining, and you cannot have taken corticosteroids for at least 1 month or botulinum toxin injections above the knee for at least 3 months prior to enrollment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of High-Intensity Treadmill Training for Multiple Sclerosis?
Research shows that intensive treadmill training, including high-intensity sessions, can significantly improve walking ability, balance, and mobility in people with multiple sclerosis. Studies have found that such training helps increase walking speed and endurance, making it a promising treatment for improving gait and overall mobility in MS patients.12345
Is high-intensity treadmill training safe for humans?
How does High-Intensity Treadmill Training differ from other treatments for multiple sclerosis?
High-Intensity Treadmill Training is unique because it combines high-intensity exercise with dynamic-stability gait training and perturbations, which can significantly improve gait resistance, mobility, and balance in people with multiple sclerosis. This approach is more effective than traditional strength training in enhancing these functional outcomes.1271011
Eligibility Criteria
This trial is for adults aged 18-65 with multiple sclerosis (MS) who can walk 10 meters, have stable MS treatments and disease course, no severe medical conditions or recent heart attacks, and are not pregnant. They must be under 135kg in weight, able to follow commands, and commit to the training program.Inclusion Criteria
I have no neurological diseases, seizures, nerve injuries in my legs, or brain injuries.
I am between 18 and 65 years old and weigh less than 135kg.
I haven't had a heart attack in the last month, my blood pressure is under control, I don't get dizzy standing up, and my diabetes is managed.
See 10 more
Exclusion Criteria
See inclusion criteria.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Assessment
Initial assessment of walking function, including gait speed, endurance, and balance
1 week
1 visit (in-person)
Treatment
Participants undergo up to 30 sessions of treadmill training over approximately 10 weeks, with varying intensity and balance perturbations
10 weeks
30 visits (in-person)
Mid-Training Assessment
Assessment of walking function after 15 training sessions
1 week
1 visit (in-person)
Post-Training Assessment
Assessment of walking function after completion of all training sessions
1-2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness six months after training
6 months
1 visit (in-person)
Treatment Details
Interventions
- High-Intensity Treadmill Training (Behavioural Intervention)
- Standard Treadmill Training (Behavioural Intervention)
- Treadmill Training with Perturbations (Behavioural Intervention)
Trial OverviewThe study tests whether high-intensity gait training on a shaky treadmill improves walking speed, balance, and community mobility in people with MS. Participants will undergo different combinations of intensity levels and stability during treadmill exercises.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Moderate-Intensity With PerturbationsExperimental Treatment2 Interventions
30 sessions of moderate-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
Group II: High-Intensity With PertubationsExperimental Treatment2 Interventions
30 sessions of high-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.
Group III: High-Intensity No PerturbationsExperimental Treatment1 Intervention
30 sessions of high-intensity treadmill training will be conducted on a stable treadmill.
Group IV: Moderate-Intensity No PerturbationsActive Control1 Intervention
30 sessions of moderate-intensity treadmill training will be conducted on a stable treadmill.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Marquette UniversityMilwaukee, WI
Rehabilitation Hospital of IndianaIndianapolis, IN
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Who Is Running the Clinical Trial?
Marquette UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
Indiana UniversityCollaborator
Medical College of WisconsinCollaborator
References
Intensive Multimodal Training to Improve Gait Resistance, Mobility, Balance and Cognitive Function in Persons With Multiple Sclerosis: A Pilot Randomized Controlled Trial. [2020]Introduction: Persons with multiple sclerosis (MS) have deficits in many aspects of physical and cognitive functioning that can impact on mobility and participation in daily life. The effect of a 4 week intensive multimodal treadmill training on functional mobility, balance, executive functions and participation in persons with MS with moderate to severe disability was investigated. Methods: Thirty eight persons with MS admitted to a rehabilitation center participated in a two arm randomized 2:1 controlled trial. Participants in the experimental group received supervised intensive treadmill training including cognitive and motor dual tasks (DT-group, N = 26), 5 sessions per week and a control group received the same amount of supervised strength training (S-group, N = 12). The participants were assessed before and after the rehabilitation period with the 2 Minutes Walking Test (2MWT), speed and, static and dynamic balance measures, the Frontal Assessment Battery and the Short Form-12 questionnaire. The main hypothesis was related to the superiority of the treadmill intervention based on a greater proportion of people making a clinically relevant gain (15% increase on 2MWT) in gait resistance following treatment. ANCOVA (Analysis of covariance) models adjusting for baseline measurement of the respective outcome variable, as well as sex and age, were used to evaluate differences in efficacy for all variables. P was set at 0.05. Results: Nineteen out of 26 persons in the DT-group made a clinically relevant gain and two out of 12 in the S-Group (P = 0.001). The DT-group improved more in gait resistance, speed and mobility (P < 0.01). Balance and executive functions instead improved moderately in both groups following training while perception of health remained similar in both groups. Conclusion: A four week multimodal training on treadmill was highly effective in augmenting gait resistance and mobility in moderately to severely affected persons with MS.
Intensity of treadmill walking exercise on acute mood symptoms in persons with multiple sclerosis. [2018]An acute bout of moderate-intensity treadmill walking exercise has previously been associated with improvements in overall mood disturbance and vigor, without worsening fatigue, among persons with multiple sclerosis (MS).This study examined the effects of light-, moderate-, and high-intensity bouts of treadmill walking exercise on immediate and delayed mood states in MS.
Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. [2022]Purpose. This systematic review critically analyzes the literature on the effectiveness of treadmill training (TT), body-weight-supported TT (BWSTT), and robot-assisted TT (RATT) in persons with multiple sclerosis (MS), with focus on gait-related outcome measurements. Method. Electronic databases (Pubmed, Pedro, Web of Science, and Cochrane Library) and reference lists of articles and narrative reviews were searched. Pre-, quasi- and true-experimental studies were included if adult persons with MS were involved in TT, BWSTT, or RATT intervention studies published before 2012. Descriptive analysis was performed and two researchers scored the methodological quality of the studies. Results. 5 true- and 3 preexperimental studies (mean quality score: 66%) have been included. In total 161 persons with MS were involved (TT, BWSTT, or RATT, 6-42 sessions; 2-5x/week; 3-21 weeks). Significant improvements in walking speed and endurance were reported. Furthermore, improvements of step length, double-support time, and Expanded Disability Status Scale were found. Conclusions. There is a limited number of published papers related to TT in persons with MS, concluding that TT, BWSTT, and RATT improve the walking speed and endurance. However, it is not clear what type of TT is most effective. RCTs with larger but more homogeneous populations are needed.
Treadmill training with partial body weight support after stroke. [2019]Treadmill therapy with partial BWS is a promising new approach to improve gait ability after stroke. This task-specific approach enables nonambulatory patients the repetitive practice of complex gait cycles instead of single-limb gait-preparatory maneuvers. Patients walk more symmetrically with less spasticity and better cardiovascular efficiency on the treadmill than with floor walking. Several controlled, clinical studies have shown the potential of treadmill training as a therapeutic intervention for nonambulatory patients with chronic stroke-related hemiplegia. Furthermore, controlled trials in acute stroke survivors have shown that treadmill training is as effective as other physiotherapy approaches that stress the repetitive practice of gait. Controlled multicenter trials comparing locomotor training with conventional therapy will be forthcoming. An electromechanical gait trainer that relieves the strenuous effort of the therapists and provides control of the trunk in a phase-dependent manner is a new technical alternative for gait training in severely impaired stroke patients.
Robot-Assisted Body-Weight-Supported Treadmill Training in Gait Impairment in Multiple Sclerosis Patients: A Pilot Study. [2019]This study deals with the use of a robot-assisted body-weight-supported treadmill training in multiple sclerosis (MS) patients with gait dysfunction. Twenty MS patients (10 men and 10 women) of the mean of 46.3 ± 8.5 years were assigned to a six-week-long training period with the use of robot-assisted treadmill training of increasing intensity of the Lokomat type. The outcome measure consisted of the difference in motion-dependent torque of lower extremity joint muscles after training compared with baseline before training. We found that the training uniformly and significantly augmented the torque of both extensors and flexors of the hip and knee joints. The muscle power in the lower limbs of SM patients was improved, leading to corrective changes of disordered walking movements, which enabled the patients to walk with less effort and less assistance of care givers. The torque augmentation could have its role in affecting the function of the lower extremity muscle groups during walking. The results of this pilot study suggest that the robot-assisted body-weight-supported treadmill training may be a potential adjunct measure in the rehabilitation paradigm of 'gait reeducation' in peripheral neuropathies.
Transfer and retention effects of gait training with anterior-posterior perturbations to postural responses after medio-lateral gait perturbations in older adults. [2021]Gait perturbations, occurring in any direction in daily life, may result in a fall. In fall prevention, gait perturbation training is a promising approach. Treadmill perturbations in anterior-posterior direction can easily be applied by accelerations or decelerations of the belt, but it is unknown whether training effects transfer to reactive recovery in medio-lateral direction. We aimed to evaluate the transfer and retention effects of gait training with treadmill perturbations in anterior-posterior direction to medio-lateral reactive recovery.
High intensity exercise training on functional outcomes in persons with multiple sclerosis: A systematic review. [2023]There is growing interest and evidence for high intensity training (HIT) in clinical populations, including persons with multiple sclerosis (MS). While HIT has been shown to be a safe modality in this group, it is still unclear what collective knowledge exists for HIT on functional outcomes. This study examined HIT modalities (e.g., aerobic, resistance, functional training) on functional outcomes such as walking, balance, postural control, and mobility in persons with MS.
Perturbation-Based Balance Training Using Repeated Trips on a Walkway vs. Belt Accelerations on a Treadmill: A Cross-Over Randomised Controlled Trial in Community-Dwelling Older Adults. [2021]Background: Walkway and treadmill induced trips have contrasting advantages, for instance walkway trips have high-ecological validity whereas belt accelerations on a treadmill have high-clinical feasibility for perturbation-based balance training (PBT). This study aimed to (i) compare adaptations to repeated overground trips with repeated treadmill belt accelerations in older adults and (ii) determine if adaptations to repeated treadmill belt accelerations can transfer to an actual trip on the walkway. Method: Thirty-eight healthy community-dwelling older adults underwent one session each of walkway and treadmill PBT in a randomised crossover design on a single day. For both conditions, 11 trips were induced to either leg in pseudo-random locations interspersed with 20 normal walking trials. Dynamic balance (e.g., margin of stability) and gait (e.g., step length) parameters from 3D motion capture were used to examine adaptations in the walkway and treadmill PBT and transfer of adaptation from treadmill PBT to a walkway trip. Results: No changes were observed in normal (no-trip) gait parameters in both training conditions, except for a small (0.9 cm) increase in minimum toe elevation during walkway walks (P < 0.01). An increase in the margin of stability and recovery step length was observed during walkway PBT (P < 0.05). During treadmill PBT, an increased MoS, step length and decreased trunk sway range were observed (P < 0.05). These adaptations to treadmill PBT did not transfer to a walkway trip. Conclusions: This study demonstrated that older adults could learn to improve dynamic stability by repeated exposure to walkway trips as well as treadmill belt accelerations. However, the adaptations to treadmill belt accelerations did not transfer to an actual trip. To enhance the utility of treadmill PBT for overground trip recovery performance, further development of treadmill PBT protocols is recommended to improve ecological authenticity.
Dynamic gait stability of treadmill versus overground walking in young adults. [2022]Treadmill has been broadly used in laboratory and rehabilitation settings for the purpose of facilitating human locomotion analysis and gait training. The objective of this study was to determine whether dynamic gait stability differs or resembles between the two walking conditions (overground vs. treadmill) among young adults. Fifty-four healthy young adults (age: 23.9±4.7years) participated in this study. Each participant completed five trials of overground walking followed by five trials of treadmill walking at a self-selected speed while their full body kinematics were gathered by a motion capture system. The spatiotemporal gait parameters and dynamic gait stability were compared between the two walking conditions. The results revealed that participants adopted a "cautious gait" on the treadmill compared with over ground in response to the possible inherent challenges to balance imposed by treadmill walking. The cautious gait, which was achieved by walking slower with a shorter step length, less backward leaning trunk, shortened single stance phase, prolonged double stance phase, and more flatfoot landing, ensures the comparable dynamic stability between the two walking conditions. This study could provide insightful information about dynamic gait stability control during treadmill ambulation in young adults.
Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. [2018]Treadmill training is used in rehabilitation might improve gait parameters of patients with Parkinson Disease. Aim of this study was to assess the effectiveness of treadmill training in improving the gait of patients with Parkinson Disease and the acceptability and safety of this type of therapy.
Split-Belt Training but Not Cerebellar Anodal tDCS Improves Stability Control and Reduces Risk of Fall in Patients with Multiple Sclerosis. [2022]The objective of this study was to examine the therapeutic potential of multiple sessions of training on a split-belt treadmill (SBT) combined with cerebellar anodal transcranial direct current stimulation (tDCS) on gait and balance in People with Multiple Sclerosis (PwMS). Twenty-two PwMS received six sessions of anodal (PwMSreal, n = 12) or sham (PwMSsham, n = 10) tDCS to the cerebellum prior to performing the locomotor adaptation task on the SBT. To evaluate the effect of the intervention, functional gait assessment (FGA) scores and distance walked in 2 min (2MWT) were measured at the baseline (T0), day 6 (T5), and at the 4-week follow up (T6). Locomotor performance and changes of motor outcomes were similar in PwMSreal and PwMSsham independently from tDCS mode applied to the cerebellum (anodal vs. sham, on FGA, p = 0.23; and 2MWT, p = 0.49). When the data were pooled across the groups to investigate the effects of multiple sessions of SBT training alone, significant improvement of gait and balance was found on T5 and T6, respectively, relative to baseline (FGA, p < 0.001 for both time points). The FGA change at T6 was significantly higher than at T5 (p = 0.01) underlining a long-lasting improvement. An improvement of the distance walked during the 2MWT was also observed on T5 and T6 relative to T0 (p = 0.002). Multiple sessions of SBT training resulted in a lasting improvement of gait stability and endurance, thus potentially reducing the risk of fall as measured by FGA and 2MWT. Application of cerebellar tDCS during SBT walking had no additional effect on locomotor outcomes.