Rehabilitation of functional muscle and motor capacity in neurodegenerative disease: Multiple Sclerosis research

ISRCTN	ISRCTN60122826
DOI	https://doi.org/10.1186/ISRCTN60122826
Protocol serial number	050078 IWT TETRA
Sponsor	IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium)
Funder	IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium) (ref: 050078)

Submission date: 19/08/2009
Registration date: 01/10/2009
Last edited: 01/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bert Eijnde
Scientific

Guffenslaan 39
Hasselt
B-3500
Belgium

Study information

Primary study design	Interventional
Study design	Single centre placebo-controlled clinical research trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Rehabilitation of functional muscle and motor capacity in neurodegenerative disease: a single centre placebo-controlled Multiple Sclerosis research trial
Study acronym	MS rehabilitation
Study objectives	Regular and moderately intense rehabilitation of muscle strength improves functional capacity in multiple sclerosis (MS) patients.
Ethics approval(s)	Ethics Board of Hasselt University approved on the 24th October 2005 (ref: CME 2005/233)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	1. Visual Analogue Scale (VAS) measured before and after each training session 2. Borg Scale measured after each training session
Completion date	01/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	48
Key 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
Key exclusion criteria	1. Any pathology that is a contra-indication for rehabilitation training 2. Wheelchair dependency 3. No present physiotherapy (preferably)
Date of first enrolment	01/11/2005
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

Belgium

Study participating centre

Guffenslaan 39

Hasselt
B-3500
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes