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

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ClinicalTrials.gov Identifier: NCT03548974
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Fa. Reck MOTOmed
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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).

  2. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Additional Information:
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Responsible Party: Prof. Dr. Klaus Pfeifer, Prof. Dr., University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT03548974     History of Changes
Other Study ID Numbers: ATRT-2015
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg:
Multiple Sclerosis
Spasticity
MOTOmed training
internet

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Muscle Spasticity
Pathologic Processes
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