Internet-based MOTOmed Exercise to Reduce Spasticity and Improve Physical Function in Persons With Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT03548974|
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Treatment group 1 Behavioral: Treatment group 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Internet-based Physical Activity Promotion Using the MOTOmed Movement Trainer to Reduce Spasticity and Improve Physical Function in Moderately to Severely Affected Persons With Multiple Sclerosis|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Active Comparator: Interventiongroup1
passive, motor-driven movement therapy followed by intermittent active and passive training
Behavioral: Treatment 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.
Active Comparator: Interventiongroup2
intermittent active and passive training followed by no intervention
Behavioral: Treatment 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)
- Change in spasticity: MSSS-88 [ Time Frame: 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 [ Time Frame: 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)
- Change in function: 5-Chair-Rise [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.