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Stroke Interventions in Clinical Trials
Printable Version
TEST-TRACS
TEchnology-Supported Task-oriented TRaining of Arm-hand function in persons with Chronic Stroke



Principal Investigator
Dr. Henk Seelen

PI Address
Zandbergsweg 111
Hoensbroek,
6432 CC
Netherlands

Contact Address
Mrs. Annick Timmermans
Zandbergsweg 111
Hoensbroek,
6432 CC
Netherlands
Phone: +31 45 5282372
FAX: +31 45 5282227

Contact Email
A.Timmermans@tue.nl

Sponsor



Study Size Planned:22
Max Time from onset:12 Months
Max Age:85
Min Age:18
Follow-up Duration:8 Weeks
ISRCTN#ISRCTN82787126
Status:
Ongoing.

Purpose:
To test if using an 8-week technology-supported task-oriented training program is better able to improves skilled arm-hand performance and quality of life in chronic stroke patients compared to task oriented training without technology.

Interventions:
Technology-Supported Task-oriented Training
Feedback about exercise performance (knowledge of performance and knowledge of results) is given both during and after exercise, based on registration of kinematic parameter information.

Location(s):
Netherlands

Year Started: 2009

Design:
Mono-center, single-blind, randomised controlled trial.

Inclusion Criteria
1. First ever stroke
2. 18-85 years old, male and female
3. Clinically diagnosed as having a central paresis of the arm/hand (strength: Medical Research Council grade 2-3-4 at entry into the study)
4. Post-stroke time >= 12 months
5. Fair-good cognitive level (Mini Mental State Examination [MMSE] score >= 26 or CogLog score >= 26)
6. Ability to read and understand Dutch language
7. Impaired as to at least two of the following skills: drinking from a cup, eating with knife and fork, open/close clothing, taking money from purse, wash/dry body, holding reek/broom/spade, grooming, keyboard work, balancing object while holding it
8. Motivated to train on above mentioned skills

Exclusion Criteria
1. Neglect: Bells Test, Letter Cancellation Test: minimum omission score of 15% is considered to indicate unilateral spatial neglect
2. Hemianopsia, retrieved from patient's medical file
3. Severe spasticity: Modified Ashworth Scale total arm >4
4. Severe additional neurological, orthopaedic or rheumatoid impairments prior to stroke that may interfere with task performance
5. Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test
6. Apraxia: Apraxietest of Van Heugten

Patient Involvement:
Patients will be randomized to one of two groups: interventional or controll group. Intervention group:
Participants train on at least two skills they select from a list of 10 skills established in prior research. Participants will receive video-based instruction of predefined task-oriented exercises required for the training. Exercises are offered with increasing difficulty levels for skill components that keep a strong relation with the skill itself. Task-oriented training will be supported by technology, i.e. upper limb kinematics will be recorded during skill performance in stroke patients while training. Feedback about exercise performance (knowledge of performance and knowledge of results) is given both during and after exercise, based on registration of kinematic parameter information. Patients train for 8 weeks at a minimum of 4 days per week, 30 minutes twice per day.

Control group:
Participants train on at least two skills from a list of 10 skills on offer. Participants will receive video-based instruction of predefined task-oriented training exercises required. Exercises are offered with increasing difficulty levels for skill components that keep a strong relation with the skill itself. Patients train for 8 weeks at a minimum of 4 days per week, 30 minutes twice per day. The control group will perform training without technology support or technology-based feedback on performance. The outcomes above will be assessed at the following timepoints:
T0: Baseline
T1: After training for 4 weeks
T2: After training for 8 weeks
T3: 6 months after finishing the training programme

Primary Outcome:
Arm-hand function:
1. As measured on function level by Brunnstrom-Fugl-Meyer Test
2. As measured on activity level by the Action Research Arm Test and the Motor Activity Log

These will be assessed at T0,T1,T2,T3

Secondary Outcome:
Quality of life at T0,T2,T3:
1. The 36-item Short Form health survey (SF-36)
2. EuroQol-6D questionnaire

Source of Information:
Controlled-trials.com

Web Links and Publications:
Adelante

TEST-TRACS
Current Controlled Trials

This information last updated on: 11/3/2009

Reviewed on: 11/02/2009.

UID: 902

   

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