Cognitive Rehabilitation and Exercise for Multiple Sclerosis
(COMBINE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kessler Foundation
Must not be taking: Steroids, Benzodiazepines
Disqualifiers: Neurological disorders, Uncontrolled psychiatric, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.
Will I have to stop taking my current medications?
If you are currently using medications that may affect thinking, like steroids or benzodiazepines, you will need to stop taking them to participate in this trial.
What data supports the effectiveness of the treatment Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL) for Multiple Sclerosis?
Research shows that combining virtual reality with physical therapy can improve balance, gait, and motor function in patients with neurological conditions like multiple sclerosis and traumatic brain injury. Virtual reality enhances motivation and engagement, which can lead to better outcomes in rehabilitation.
12345Is the combination of exercise and virtual reality generally safe for humans?
Research shows that using virtual reality with exercise is generally safe for humans, with no major adverse events reported in studies involving mild cognitive impairment and neck rehabilitation.
678910How does the Cognitive Rehabilitation and Exercise treatment for Multiple Sclerosis differ from other treatments?
This treatment is unique because it combines cognitive rehabilitation with physical exercise, addressing both mental and physical impairments in MS. Unlike standard treatments that may focus solely on physical rehabilitation, this approach aims to improve cognitive function and overall quality of life through a holistic method.
25111213Eligibility Criteria
This trial is for adults aged 18-70 with Multiple Sclerosis, who primarily speak English and have moderate mobility issues but are currently inactive. They must not have had a relapse or taken steroids in the last month and should be right-handed. People with other neurological disorders, uncontrolled psychiatric conditions, contraindications to exercise, certain medications affecting cognition, pregnancy, or MRI contraindications cannot participate.Inclusion Criteria
I have some difficulty walking or moving around.
I haven't had a relapse or taken steroids in the last 30 days.
Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ)
+4 more
Exclusion Criteria
Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
I have no neurological disorders other than MS and my mental health is stable.
Currently pregnant
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-intervention
Baseline assessments including fMRI and memory tests conducted
2 weeks
2 visits (in-person)
Treatment
Participants undergo cognitive rehabilitation combined with either aerobic exercise with VR or stretching and toning for 12 weeks
12 weeks
3 visits per week (in-person)
Post-intervention
Post-treatment assessments including fMRI and memory tests conducted
2 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if combining cognitive rehabilitation (using Kessler Foundation's modified Story Memory Technique) with physical exercises (stretching/toning and aerobic training enhanced by virtual reality) can improve new learning and memory in people with Multiple Sclerosis who also have mobility disabilities.
2Treatment groups
Experimental Treatment
Group I: Cognitive Rehabilitation + Stretching and ToningExperimental Treatment2 Interventions
In the cognitive rehabilitation and stretching and toning (S/T) exercise condition, participants will complete 12 weeks of supervised S/T activities 3 days per week over the 12 week period. For seven weeks, participants will only complete S/T. During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
Group II: Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)Experimental Treatment2 Interventions
In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning/memory; IDEAL) three days per week over a 12 week period. For seven weeks, participants will only complete IDEAL. For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kessler FoundationEast Hanover, NJ
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Who Is Running the Clinical Trial?
Kessler FoundationLead Sponsor
National Multiple Sclerosis SocietyCollaborator
References
Robotic gait training in multiple sclerosis rehabilitation: Can virtual reality make the difference? Findings from a randomized controlled trial. [2022]Gait, coordination, and balance may be severely compromised in patients with multiple sclerosis (MS), with considerable consequences on the patient's daily living activities, psychological status and quality of life. For this reason, MS patients may benefit from robotic-rehabilitation and virtual reality training sessions. Aim of the present study was to assess the efficacy of robot-assisted gait training (RAGT) equipped with virtual reality (VR) system in MS patients with walking disabilities (EDSS 4.0 to 5.5) as compared to RAGT without VR. We enrolled 40 patients (randomized into two groups) undergoing forty RAGT±VR sessions over eight weeks. All the patients were assessed at baseline and at the end of the treatment by using specific scales. Effect sizes were very small and non-significant between the groups for Berg Balance Scale (-0.019, CI95% -2.403 to 2.365) and TUG (-0.064, 95%CI -0.408 to 0.536) favoring RAGT+VR. Effects were moderate-to-large and significant for positive attitude (-0.505, 95%CI -3.615 to 2.604) and problem-solving (-0.905, 95%CI -2.113 to 0.302) sub-items of Coping Orientation to Problem Experienced, thus largely favoring RAGT+VR. Our findings show that RAGT combined with VR is an effective therapeutic option in MS patients with walking disability as compared to RAGT without VR. We may hypothesize that VR may strengthen RAGT thanks to the entrainment of different brain areas involved in motor panning and learning.
The effect of balance training on postural control in people with multiple sclerosis using the CAREN virtual reality system: a pilot randomized controlled trial. [2022]Multiple sclerosis (MS) is a multi-focal progressive disorder of the central nervous system often resulting in diverse clinical manifestations. Imbalance appears in most people with multiple sclerosis (PwMS). A popular balance training tool is virtual reality (VR) with several advantages including increased compliance and user satisfaction. Therefore, the aim of this pilot RCT (Trial registration number, date: ISRCTN14425615, 21/01/2016) was to examine the efficacy of a 6-week VR balance training program using the computer assisted rehabilitation environment (CAREN) system (Motek Medical BV, Amsterdam, Netherlands) on balance measures in PwMS. Results were compared with those of a conventional balance exercise group. Secondary aims included the impact of this program on the fear of falling.
Improved Balance, Gait, and Lower Limb Motor Function in a 58-Year-Old Man with Right Hemiplegic Traumatic Brain Injury Following Virtual Reality-Based Real-Time Feedback Physical Therapy. [2023]BACKGROUND This report presents the case of a 58-year-old man with right hemiplegia who improved his gait and lower limb motor function following virtual reality (VR)-based physical therapy. The use of augmented reality or VR-based technology is being increasingly used to support physical therapy in patients with motor deficits and to improve gait, and can be used in small hospitals and outpatient departments. CASE REPORT A 58-year-old man was diagnosed with left hemiplegia due to traumatic brain injury (TBI). He received 20 minutes of VR-based real-time feedback gait training and 30 minutes of general physical therapy, 5 times a week for 8 weeks. BioRescue was used for measurement of balance, GAITRite was used for measurement of gait, and Fugl-Meyer assessment was used for lower extremity motor function measurement. These were measured before the intervention and at 2, 4, 6, and 8 weeks after the intervention. After the intervention, center of pressure and limits of stability also increased. The affected step length, stride length, affected single support, and cadence were significantly increased after VR-based real-time feedback. Additionally, his lower extremity motor function score increased from 18 to 23 points. CONCLUSIONS This case report supports recent studies that have shown the value of VR-based methods as part of a physical therapy program in patients with problems with gait and motor function, including patients with stroke. VR-based real-time feedback showed favorable effects on rehabilitation following a TBI.
The influence of information processing speed on benefit from learning and memory rehabilitation in TBI: a sub-analysis of the TBI-MEM trial. [2023]This study examined the influence of processing speed (PS) on benefit from treatment with the Kessler Foundation modified Story Memory Technique® (KF-mSMT®), a cognitive rehabilitation intervention shown to improve new learning and memory in traumatic brain injury (TBI).
Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. [2019]Motivated patients are more likely to adhere to treatment resulting in better outcomes. Virtual reality rehabilitation (VRR) is a treatment approach that includes video gaming to enhance motivation and functional training.
Virtual Reality "exergames": A promising countermeasure to improve motivation and restorative effects during long duration spaceflight missions. [2022]Long duration spaceflight missions will require novel exercise systems to protect astronaut crew from the detrimental effects of microgravity exposure. The SPRINT protocol is a novel and promising exercise prescription that combines aerobic and resistive training using a flywheel device, and it was successfully employed in a 70-day bed-rest study as well as onboard the International Space Station. Our team created a VR simulation to further augment the SPRINT protocol when using a flywheel ergometer training device (the Multi-Mode Exercise Device or M-MED). The simulation aspired to maximal realism in a virtual river setting while providing real-time biometric feedback on heart rate performance to subjects. In this pilot study, five healthy, male, physically-active subjects aged 35 ± 9.0 years old underwent 2 weeks of SPRINT protocol, either with or without the VR simulation. After a 1-month washout period, subjects returned for a subsequent 2 weeks in the opposite VR condition. We measured physiological and cognitive variables of stress, performance, and well-being. While physiological effects did not suggest much difference with the VR condition over 2 weeks, metrics of motivation, affect, and mood restoration showed detectable differences, or trended toward more positive outcomes than exercise without VR. These results provide evidence that a well-designed VR "exergaming" simulation with biometric feedback could be a beneficial addition to exercise prescriptions, especially if users are exposed to isolation and confinement.
Application of a mild traumatic brain injury rehabilitation program in a virtual realty environment: a case study. [2011]Mild traumatic brain injury (mTBI) can compromise reaction time, visual perception, memory, attention, balance, and gait. These deficits, especially if persistent, can restrict participation in daily activities and the resumption of personal and profession roles. The purpose of this case study is to describe an mTBI-specific clinical assessment and rehabilitation intervention administered in a virtual reality environment.
Improving cognitive function after brain injury: the use of exercise and virtual reality. [2022]To assess the impact of exercise and virtual reality (VR) on the cognitive rehabilitation of persons with traumatic brain injury (TBI).
The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]Individuals with mild cognitive impairment are at risk of cognitive and physical decline. Virtual reality (VR) exercise may provide beneficial physical and cognitive exercise. The objectives of this study were to assess the feasibility and safety of home-based VR exercise and to provide pilot data for physical and cognitive efficacy. Eleven individuals with mild cognitive impairment (seven males/four females, average 78 years old, and average 3 years since diagnosis) performed a 30-min home-based VR exercise program 5 days a week for 6 weeks. The VR platform was successfully installed in participants' homes, and all participants were able to learn the VR program and progress. Participants completed 99% of the prescribed exercise. There were no major adverse events. Most participants enjoyed the VR program and reported physical benefits; fewer reported cognitive benefits. No physical or cognitive outcome measures showed change after 6 weeks. Home-based VR exercise is safe and feasible in individuals with mild cognitive impairment.
Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? [2023]Objective: Physical rehabilitation by virtual reality (VR) gamification is gaining acceptance. This study was designed to verify whether neck movements invoked by a fully immersive VR game environment may be physiotherapist-prescribed rehabilitation exercise. Methods: This was a single-visit prospective clinical trial (NCT03104647). Healthy participants put on VR headsets and entered a fully immersive game environment (VRPhysio, XRHealth, Tel Aviv, Israel) that prompted neck movement (flexion, extension, rotation, lateral bend, and combinations repeated twice in random order) accompanied by feedback encouraging correct performance. Four board-certified physiotherapists independently viewed videotapes recorded during the session, identified movements, and determined whether they were recommended as neck rehabilitation exercises. Results: Twenty (n = 20) participants (male-female ratio = 13:7; age = 38 ± 14 years old) completed the training session (16 movements per participant). All movements were identified correctly and determined to be appropriate for neck rehabilitation. No adverse events were reported. Conclusions: The VRPhysio software invoked movements identified by board-certified physiotherapists as appropriate for neck rehabilitation. The potential advantage of home-based VR gamification of cervical spine rehabilitation programs over common practice in motivating patient adherence warrants evaluation by randomized controlled trials.
Exercise and rehabilitation for individuals with multiple sclerosis. [2022]It is the coexistence of physical and cognitive impairments, together with emotional and social issues in a disease with an uncertain course, that makes MS rehabilitation unique and challenging. Inpatient rehabilitation improves functional independence but has only limited success improving the level of neurologic impairment. Benefits are usually not long lasting. Severely disabled people derive equal or more benefit than those who are less disabled, but cognitive problems and ataxia tend to be refractory. There is now good evidence that exercise can improve fitness and function for those with mild MS and helps to maintain function for those with moderate to severe disability. Therapy can be performed over 6 to 15 weeks in outpatient or home-based settings or as a weekly day program lasting several months. Several different forms of exercise have been investigated. For most individuals, aerobic exercise that incorporates a degree of balance training and socialization is recommended. Time constraints, access, impairment level, personal preferences, motivations, and funding sources influence the prescription for exercise and other components of rehabilitation. Just as immunomodulatory drugs must be taken on a continual basis and be adjusted as the disease progresses, so should rehabilitation be viewed as an ongoing process to maintain and restore maximum function and QOL.
Effectiveness of Virtual Reality Rehabilitation in Persons with Multiple Sclerosis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]Multiple Sclerosis (MS) is a chronic disease with physical, cognitive, and psychosocial impairments. Virtual Reality (VR) has been used as an innovative tool in neurological rehabilitation. There are promising new studies that have used commercial video games consoles for the rehabilitation of people with MS.
Effects of a resistance training program in multiple sclerosis Spanish patients: a pilot study. [2019]Physical exercise is regarded as a useful tool in the treatment of multiple sclerosis (MS). Generally, physical rehabilitation have been based on the prescription of aerobic exercises, while fewer programs have been aimed at developing muscular strength.