Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Spasticity, MOTOmed training, internet
Brief summary
In an RCT, the effect of the MOTOmed movement trainer (Reck, Germany) on spasticity and physical function in pwMS with EDSS score between 4,5 and 7 is investigated. All subjects exercise at home and are supervised and supported by an exercise therapist via an online platform. We compare the effect of a 12 week passive, motor-driven movement therapy (VG1) to an intermittent active and passive training (VG2). After 12 weeks, VG1 continues with an active training including strengthening exercises for another 12 weeks. VG2 does not receive any intervention in the second study phase.
Interventions
BEHAVIORALTreatment group 1
The ms-intakt/MOTOmed-intervention is a home-based program using the MOTOmed movement trainer: 12 week passive, motor-driven movement therapy followed by 12 weeks of intermittent active and passive training after the 3month assessment. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. Therapists aimed at eliciting a BORG Feedback of between 10 (fairly light) and 15 (hard). The exercise training was home-based and supervised via the internet.
BEHAVIORALTreatment group 2
The subjects assigned to interventiongroup2 started with 12 weeks intermittent active and passive training followed by 12 weeks of no intervention (Wash out phase)
Sponsors
Fa. Reck MOTOmed
University of Erlangen-Nürnberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
diagnosed Multiple Sclerosis (McDonald criteria) EDSS score between 5,5 and 7 diagnosed spasticity access to the internet
Exclusion criteria
lack of medical certificate for physical activity cognitive impairment clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spasticity: MSSS-88 | Assessments took place at baseline, at 3 and 6 months | This questionnaire contains 88 items, which represent the impairment by the spasticity in various subscales. The total score ranges from 88 to a maximum of 352 points (maximum impairment). |
| Change in sSpasticity: Modified Tardieu scale | Assessments took place at baseline, at 3 and 6 months | The scale is measuring spasticity as response to passive movement at both slow and fast speed; scored 0 - 4. (0=no resistance; 4= inexhaustible clonus) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in function: 5-Chair-Rise | Assessments took place at baseline, at 3 and 6 months | The main task in this test is to get up and sit down 5 times as fast as possible without use of the arms. The goal is the global assessment of the strength of the lower limb. |
| Change in function: 25foot-walk-test | Assessments took place at baseline, at 3 and 6 months | The task is to walk a 25foot distance as fast as possible. This test measures the functionality of the lower extremity and the walking speed. |
| Change in function: 2min-walk | Assessments took place at baseline, at 3 and 6 months | The subject is asked to walk with the fastest, possible speed to cover the greatest possible distance in 2min. |
Outcome results
None listed