Technology-supported task-oriented training of arm-hand function in persons with chronic stroke
| ISRCTN | ISRCTN82787126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82787126 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2008
- Registration date
- 17/04/2008
- Last edited
- 01/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery (ischaemic stroke) or a bleed (haemorrhagic stroke). One of the most common long-term complications of stroke is weakness or paralysis of one side of the body. It has been found that around 50% of stroke patients are left with limit use of one of their hands/arms, which can make every day activities, such as getting dressed or carrying things, very difficult. Traditionally, stroke patients undergo extensive physiotherapy and occupational therapy in order to try and regain function in their hand/arm. In recent years however, robotics are being used more and more to support this rehabilitation. The Haptic Master robotic system is a commercially available robot which attaches to the patients arm to support training of real-life tasks such as reaching, grabbing and object transportation. The aim of this study is to test the effectiveness of this system in the rehabilitation of stroke survivors with hand/arm weakness.
Who can participate?
Adults who had their first stroke at least one year ago who have hand/arm weakness.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive the task-oriented robot-assisted arm-hand training. The training involves at least two pre-specified skills (such as “eating with a knife and fork” or “using a tray”), with support from the robotic system Haptic Master. The training sessions take place twice a day, four times a week for a period of eight weeks, and involve performing a series of exercises which put together comprise the skill they are learning. Those in the second group receive video instructions to explain the exercises and train on the same schedule but without assistance from the robotic system. Before, halfway through and after the training program, as well as six months later, participants in both groups have their hand/arm function assessed, as well as completing a number of questionnaires about their quality of life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Medical Center Hoensbroek (Netherlands)
When is the study starting and how long is it expected to run for?
February 2016 to August 2017
Who is funding the study?
Heidelberg University (Germany)
Who is the main contact?
Dr Markus W. Haun
markus.haun@med.uni-heidelberg.de
Contact information
Scientific
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands
| Phone | +31 45 5282372 |
|---|---|
| A.Timmermans@tue.nl |
Study information
| Study design | Multi-centre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | TEchnology-Supported Task-oriented TRaining of Arm-hand function in persons with Chronic Stroke: a multicentre, single-blind, randomised controlled trial |
| Study acronym | TEST-TRACS |
| Study hypothesis | An 8-week technology-supported task-oriented training program improves skilled arm-hand performance and quality of life in chronic stroke patients. This improvement is larger after technology supported task-oriented training than after task-oriented training without technology support. Differences in improvement of skilled arm-hand performance between training conditions will last for at least 6 months. Please note that as of 09/02/09 this record was updated to include an amended anticipated start date. The initial anticipated start date was 01/09/2008. |
| Ethics approval(s) | The study was approved by the Medical Ethics Committee of Rehabilitation Foundation Limburg on 7th July 2008 (ref: METC-08-0006; NL23303.022.08) |
| Condition | Stroke/Neurorehabilitation |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 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 |
| Secondary outcome measures | Quality of life at T0, T2 and T3: 1. The 36-item Short Form health survey (SF-36) 2. EuroQol-6D questionnaire T0: Baseline T1: After training for 4 weeks T2: After training for 8 weeks T3: 6 months after finishing the training programme |
| Overall study start date | 01/03/2009 |
| Overall study end date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant 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 greater than or equal to 12 months 5. Fair-good cognitive level (Mini Mental State Examination [MMSE] score greater than or equal to 26 or CogLog score greater than or equal to 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 |
| Participant 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 greater than 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 |
| Recruitment start date | 01/03/2009 |
| Recruitment end date | 30/06/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hoensbroek
6432 CC
Netherlands
Sponsor information
Hospital/treatment centre
c/o Dr Henk Seelen
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands
| Website | http://www.srl.nl |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/03/2014 | Yes | No | |
| Results article | results | 13/05/2014 | Yes | No |
Editorial Notes
01/04/2016: Plain English summary added.
