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

NCT03548974 | Completed

• 1 other identifier: ATRT-2015
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Spasticity; MOTOmed training; internet

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change in function: 5-Chair-Rise

  Assessments took place at baseline, at 3 and 6 months

• Change in function: 25foot-walk-test

  Assessments took place at baseline, at 3 and 6 months

• Change in function: 2min-walk

  Assessments took place at baseline, at 3 and 6 months

Study Arms (2)

Interventiongroup1

ACTIVE COMPARATOR

passive, motor-driven movement therapy followed by intermittent active and passive training

Behavioral: Treatment group 1

Interventiongroup2

ACTIVE COMPARATOR

intermittent active and passive training followed by no intervention

Behavioral: Treatment group 2

Interventions

Treatment group 1 BEHAVIORAL

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.

Interventiongroup1

Treatment group 2 BEHAVIORAL

The subjects assigned to interventiongroup2 started with 12 weeks intermittent active and passive training followed by 12 weeks of no intervention (Wash out phase)

Interventiongroup2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed Multiple Sclerosis (McDonald criteria) EDSS score between 5,5 and 7 diagnosed spasticity access to the internet

You may not qualify if:

• lack of medical certificate for physical activity cognitive impairment clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Fa. Reck MOTOmed: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: June 7, 2018
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 7, 2018

Record last verified: 2018-05