Treadmill Training for Post-Stroke Paresis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ko, Mansoo
Disqualifiers: Orthopedic, Psychiatric, Neurological, Diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Split-belt treadmill training for post-stroke paresis?
Research shows that split-belt treadmill training helps improve walking symmetry in stroke patients by reducing step length differences between legs, and these improvements last for at least a month after training. This therapy also enhances muscle activity and joint movement, making it a promising option for long-term recovery.
12345Is split-belt treadmill training safe for humans?
Research on split-belt treadmill training, including studies with healthy adults and stroke patients, does not report any significant safety concerns. The training appears to be safe, with no negative effects observed on muscle function after repeated sessions.
12467How is split-belt treadmill training different from other treatments for post-stroke paresis?
Split-belt treadmill training is unique because it uses a treadmill with two belts moving at different speeds to help retrain walking patterns, promoting better symmetry and balance in people who have had a stroke. This approach specifically targets the differences in muscle activation and gait deviations, which are not addressed by traditional overground walking or other treadmill therapies.
12589Eligibility Criteria
This trial is for healthy individuals and stroke survivors over 20 years old. Healthy participants must walk independently without aids, while those with a history of stroke should be able to walk with or without assistance and have had their first unilateral stroke at least 6 months prior without major complications.Inclusion Criteria
People who are 20 years old or older and in good health.
You can walk at least 10 meters without any help, at a speed that feels good for you.
Healthy participants will be required to be medically stable
+7 more
Exclusion Criteria
You have unstable chest pain.
You have peripheral vascular disease.
Your diabetes is not well controlled, for example, if you have foot ulcers.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Assessment
Baseline assessment of spatiotemporal patterns and kinematic representation before treadmill walking
1 day
1 visit (in-person)
Gait Training
Participants undergo gait training using split-belt and single belt treadmill walking with neuromechanical and biobehavioral approaches
20-30 minutes per session
Multiple sessions over the study period
Follow-up
Participants are monitored for safety and effectiveness after gait training
4 weeks
Participant Groups
The study tests two types of treadmill training: split-belt and single belt using simulation software. It aims to improve walking symmetry in people who have experienced a stroke by combining strength and aerobic exercises.
2Treatment groups
Experimental Treatment
Active Control
Group I: Gait training for strokeExperimental Treatment1 Intervention
Group II: Gait training for healthyActive Control1 Intervention
Split-belt treadmill training is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Split-belt treadmill training for:
- Rehabilitation of gait asymmetry in post-stroke hemiparesis
🇪🇺 Approved in European Union as Split-belt treadmill therapy for:
- Gait rehabilitation in stroke survivors
- Improvement of step length symmetry in post-stroke hemiparesis
🇨🇦 Approved in Canada as Split-belt treadmill training for:
- Rehabilitation of gait disorders in post-stroke patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
School of Health Profession, University of Texas Medical BranchGalveston, TX
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Who Is Running the Clinical Trial?
Ko, MansooLead Sponsor
Mansoo KoLead Sponsor
References
Improved hemiparetic muscle activation in treadmill versus overground walking. [2007]Treadmill training is a promising tool for retraining gait after stroke. The treadmill induces an immediate shift toward symmetry and longer paretic stance times due to altered muscle activation (active) or the motorized belt (passive). The authors investigated vastus lateralis and medial hamstrings activation differences between treadmill and overground walking in participants with stroke.
Efficacy of Aquatic Treadmill Training on Gait Symmetry and Balance in Subacute Stroke Patients. [2020]To determine the efficacy of aquatic treadmill training (ATT) as a new modality for stroke rehabilitation, by assessing changes in gait symmetry, balance function, and subjective balance confidence for the paretic and non-paretic leg in stroke patients.
The influence of treadmill inclination on the gait of ambulatory hemiparetic subjects. [2016]This study evaluated the influence of the degree of treadmill belt inclination for training of ambulatory patients with hemiparetic stroke.
Lower limb joint moments on the fast belt contribute to a reduction of step length asymmetry over ground after split-belt treadmill training in stroke: A pilot study. [2021]The main goal was to investigate changes in muscle activity and joint moments related to step length (SL) symmetry improvements in individuals poststroke following repeated split-belt treadmill (SBT) walking. Twelve individuals with a first unilateral cerebral stroke presenting initial SL asymmetry (ratio = 1.10-2.05), and mean time post stroke 23 (SD 24.7 months) were included. Participants were trained during six sessions of SBT walking using an error-augmentation protocol. The training resulted in a reduction in SL asymmetry during walking over ground retained over 1-month post-training (p = 0.002). Significant increases in SL and joint moments (plantarflexors: 20-60%, knee flexors: 20-60% and hip extensors: 0-20% of the gait cycle) were observed on the side trained on the fast belt (effect size from 0.41 to 0.60). The improvement in SL symmetry was observed with an increase in plantarflexion joint moment symmetry. Changes in muscle activity varied among participants. In contrast to previous findings with a single exposure to SBT-training, our results showed no negative effects on paretic plantarflexors when walking over ground after repeated exposure to SBT walking. These findings justify larger trials to gain more solid information on the current protocol which appears as an efficient training for long-term recovery on SL asymmetry and on affected plantarflexors.
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.
Treadmill training and body weight support for walking after stroke. [2022]Treadmill training, with some body weight supported using a harness, is a method of treating walking after stroke. Systematic review is required to assess the cost, effectiveness and acceptance of this treatment.
Limping on split-belt treadmills implies opposite kinematic and dynamic lower limb asymmetries. [2019]Walking on a split-belt treadmill (each of the two belts running at a different speed) has been proposed as an experimental paradigm to investigate the flexibility of the neural control of gait and as a form of therapeutic exercise. However, the scarcity of dynamic investigations challenges the validity of the available findings. The aim of the present study was to investigate the dynamic asymmetries of lower limbs of healthy adults during adaptation to gait on a split-belt treadmill. Ten healthy adults walked on a split-belt treadmill mounted on force sensors, with belts running either at the same speed ('tied' condition) or at different speeds ('split' condition, 0.4 vs. 0.8 or 0.8 vs. 1.2 m/s). The sagittal power and work provided by ankle, knee and hip joints, joint rotations, muscle lengthening, and surface electromyography were recorded simultaneously. Various tied/split walking sequences were requested. In the split condition a marked asymmetry between the parameters recorded from each of the two lower limbs, in particular from the ankle joint, was recorded. The work provided by the ankle (the main engine of body propulsion) was 4.8 and 2.2 times higher (in the 0.4 vs. 0.8, and 0.8 vs. 1.2 m/s conditions, respectively) compared with the slower side, and 1.2 and 1.1 times higher compared with the same speed in the tied condition. Compared with overground gait in hemiplegia, split gait entails an opposite spatial and dynamic asymmetry. The faster leg mimics the paretic limb temporally, but the unimpaired limb from the spatial and dynamic point of view. These differences challenge the proposed protocols of split gait as forms of therapeutic exercise.
Treadmill training and body weight support for walking after stroke. [2018]Treadmill training, with or without some body weight supported using a harness, is a method of treating walking after stroke. A systematic review is required to assess the cost, effectiveness, and acceptability of this treatment.
Gait deviations associated with post-stroke hemiparesis: improvement during treadmill walking using weight support, speed, support stiffness, and handrail hold. [2022]By comparing treadmill walking in hemiparetic and non-disabled individuals at matched speeds, Chen et al. [Chen G, Patten C, Kothari DH, Zajac FE. Gait differences between individuals with post-stroke hemiparesis and non-disabled controls at matched speeds. Gait Posture (2004)] identified gait deviations that were consistent with impaired swing initiation and single limb support in the paretic limb and related compensatory strategies. Treadmill training with harness support is a promising, task-oriented approach to restoring locomotor function in individuals with post-stroke hemiparesis. To provide a rationale for the proper selection of training parameters, we assessed the potential of body weight support, treadmill speed, support stiffness, and handrail hold to improve the identified gait deviations associated with hemiparesis during treadmill walking. In the six hemiparetic subjects studied, the adjustment of each training parameter was found to improve a specific set of the gait deviations. With increased body weight support or the addition of handrail hold, percentage single limb support time on the paretic limb increased and temporal symmetry improved. With increased treadmill speed, leg kinetic energy at toe-off in the paretic limb increased but remained low relative to values in the non-paretic limb. With increased support stiffness, the exaggerated energy cost associated with raising the trunk during pre-swing and swing of the paretic limb was improved. We conclude that the proper selection of training parameters can improve the gait pattern practiced by individuals with hemiparesis during treadmill training and may improve treatment outcome.