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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Treatment group 1

Treatment group 2

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Spasticity, MOTOmed training, internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Interventiongroup1

Interventiongroup2

Arm Description

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

intermittent active and passive training followed by no intervention

Outcomes

Primary Outcome Measures

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).

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)

Secondary Outcome Measures

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.

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.

Change in function: 2min-walk

The subject is asked to walk with the fastest, possible speed to cover the greatest possible distance in 2min.

Full Information

NCT ID

NCT03548974

First Posted

November 2, 2017

Last Updated

May 24, 2018

Sponsor

University of Erlangen-Nürnberg

Collaborators

Fa. Reck MOTOmed

1. Study Identification

Unique Protocol Identification Number

NCT03548974

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Erlangen-Nürnberg

Collaborators

Fa. Reck MOTOmed

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, Spasticity, MOTOmed training, internet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventiongroup1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Interventiongroup2

Arm Type

Active Comparator

Arm Description

intermittent active and passive training followed by no intervention

Intervention Type

Behavioral

Intervention Name(s)

Treatment group 1

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Treatment group 2

Intervention Description

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 Measure Information:

Title

Change in spasticity: MSSS-88

Description

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).

Time Frame

Assessments took place at baseline, at 3 and 6 months

Title

Change in sSpasticity: Modified Tardieu scale

Description

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)

Time Frame

Assessments took place at baseline, at 3 and 6 months

Secondary Outcome Measure Information:

Title

Change in function: 5-Chair-Rise

Description

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.

Time Frame

Assessments took place at baseline, at 3 and 6 months

Title

Change in function: 25foot-walk-test

Description

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.

Time Frame

Assessments took place at baseline, at 3 and 6 months

Title

Change in function: 2min-walk

Description

The subject is asked to walk with the fastest, possible speed to cover the greatest possible distance in 2min.

Time Frame

Assessments took place at baseline, at 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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