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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548974
• Other study ID #: ATRT-2015
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: May 2018
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis

Intervention

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.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Fa. Reck MOTOmed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in spasticity: MSSS-88	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).	Assessments took place at baseline, at 3 and 6 months
Primary	Change in sSpasticity: Modified Tardieu scale	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)	Assessments took place at baseline, at 3 and 6 months
Secondary	Change in function: 5-Chair-Rise	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.	Assessments took place at baseline, at 3 and 6 months
Secondary	Change in function: 25foot-walk-test	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.	Assessments took place at baseline, at 3 and 6 months
Secondary	Change in function: 2min-walk	The subject is asked to walk with the fastest, possible speed to cover the greatest possible distance in 2min.	Assessments took place at baseline, at 3 and 6 months

External Links

•   Link to the internet training platform, individual logins for every participant
•   Official project platform for participants (german)