N/A
N=379
Comparative Effectiveness Study Telerehab Versus Conventional
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03468868 ↗Enrolled (actual)
379
Serious AEs
2.6%
Results posted
Dec 2024
Primary outcome: Primary: Timed 25 Foot Walk Test (T25FWT) — 2.88; 2.62; 3.41; 3.26 feet per second — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise program for people with MS (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shepherd Center, Atlanta GA
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timed 25 Foot Walk Test (T25FWT) |
2.88; 2.62; 3.41; 3.26 | <0.01 sig |
| SECONDARY Six Minute Walk Test (6MWT) |
963.3; 884.2; 1099.6; 1027.1 | 0.16 |
| SECONDARY Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire |
61.36; 62.45; 53.54; 58.25 | 0.13 |
| SECONDARY Godin Leisure-Time Physical Activity (LTPA) Questionnaire |
7.48; 7.56; 23.09; 22.21 | 0.70 |
| SECONDARY Quality of Life in Neurological Disorders (Neuro-QOL) Survey |
16.88; 17.19; 15.41; 14.75; 13.58; 13.90 | 0.43 |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS)-29 |
39.63; 41.59; 32.18; 34.65; 31.71; 33.01 | 0.34 |
| SECONDARY Modified Fatigue Impact Scale (MFIS) |
14.54; 14.96; 12.00; 11.63; 20.02; 20.98 | 0.74 |
| SECONDARY Expanded Disability Status Scale (EDSS) |
5.32; 5.25; 5.02; 5.04 | 0.87 |
| SECONDARY Patient Determined Disease Steps (PDDS) |
4.26; 4.28; 1.66; 2.19 | 0.05 |
Summary
This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.
Eligibility Criteria
Inclusion Criteria
- Mild to moderate MS
- Has limitations in walking but can walk 25 feet
- Does not participate in a rigorous exercise program
- Can travel to trial site for assessments and training
Exclusion Criteria
- Relapse in the past 30 days
- Other neurological or musculoskeletal disorders
Data sourced from ClinicalTrials.gov (NCT03468868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.