Internet-based MOTOmed Exercise to Reduce Spasticity and Improve Physical Function in Persons With Multiple Sclerosis

Sponsor

University of Erlangen-Nürnberg (Other)

Overall Status

Completed

CT.gov ID

NCT03548974

Collaborator

Fa. Reck MOTOmed (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Treatment group 1 Behavioral: Treatment group 2	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Jan 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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