Condition category
Nervous System Diseases
Date applied
19/08/2009
Date assigned
01/10/2009
Last edited
01/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bert Eijnde

ORCID ID

Contact details

Guffenslaan 39
Hasselt
B-3500
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

050078 IWT TETRA

Study information

Scientific title

Rehabilitation of functional muscle and motor capacity in neurodegenerative disease: a single centre placebo-controlled Multiple Sclerosis research trial

Acronym

MS rehabilitation

Study hypothesis

Regular and moderately intense rehabilitation of muscle strength improves functional capacity in multiple sclerosis (MS) patients.

Ethics approval

Ethics Board of Hasselt University approved on the 24th October 2005 (ref: CME 2005/233)

Study design

Single centre placebo-controlled clinical research trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multiple sclerosis

Intervention

Patients will be subjected to different rehabilitation modes during a period of 24 weeks and according to a specific treatment protocol:
1. Control
2. Strength training
3. Strength training and electro-stimulation
4. Whole body vibration
5. Micro-electrotherapy

At baseline and following 12 and 24 weeks of therapy all endpoints will be measured.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at baseline, mid- (after 10 weeks intervention) and post-treatment (after 20 weeks of intervention):
1. Maximal isometric muscle strength of knee-extensors and flexors
2. Isotonic and isokinetic dynamic muscle strength using an isokinetic dynamometer
3. Functional performances
4. Blood samples
5. Motor control (surface electromyography [sEMG], in-phase and anti-phase motor coordination test equipment)
6. Quality of life (specific questionnaire) assessment

Secondary outcome measures

1. Visual Analogue Scale (VAS) measured before and after each training session
2. Borg Scale measured after each training session

Overall trial start date

01/11/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. MS patients (Expanded Standard Disbility Status Scale [EDSS] 0.5 - 3) that have functional muscle and motor functional disabilities
2. Males and females aged 20 - 65 years
3. 24-week availability

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48 patients subjected to four different rehabilitation modes

Participant exclusion criteria

1. Any pathology that is a contra-indication for rehabilitation training
2. Wheelchair dependency
3. No present physiotherapy (preferably)

Recruitment start date

01/11/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Belgium

Trial participating centre

Guffenslaan 39
Hasselt
B-3500
Belgium

Sponsor information

Organisation

IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium)

Sponsor details

Bischoffsheimlaan 25
Brussel
B-1000
Belgium

Sponsor type

Research organisation

Website

http://www.iwt.be/

Funders

Funder type

Research organisation

Funder name

IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium) (ref: 050078)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes