It is the goal of this study to evaluate the additional value of the Philips Rehabilitation Exerciser for task-oriented training of arm-hand function in chronic stroke patients. Research questions:1) Does an 8 week technology-assisted task-oriented…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Fugl-Meyer test
- Action Research Arm test
- Motor Activity Log
- SF-36
- EuroQoL
Secondary outcome
- kinematics of arm, hand and trunk
- Goal Attainment scaling
- Diary: therapy compliance
Background summary
Because of improving healthcare, the age of the population increases, leading
to an increased incidence of stroke of about 30% in the next 30 years.
About 40% of stroke patients suffer from chronic impairment in arm hand
function, affecting their activity and participation level. Functional gains
can be made by addressing latent sensorimotor potential, also in the chronic
stage after stroke.
It is very much questionable if paramedical staff can accommodate the increase
in the need for care. In this light, the development of technology to support
training of arm and hand function in stroke patients can be seen as a welcome
opportunity.
In SRL, Hoensbroek, training protocols have been developed for task-oriented
arm training (TOAT). TOAT offers training of skills by offering functional
components that keep a strong relationship with the skill itself. Exercises
are offered with increasing difficulty levels. Following skills can be trained:
drinking from a cup , eating with knife and fork, open and close clothing,
taking money from purse, wash/dry body, holding reek/broom/spade, grooming,
balancing object while holding it, keyboard work.
Study objective
It is the goal of this study to evaluate the additional value of the Philips
Rehabilitation Exerciser for task-oriented training of arm-hand function in
chronic stroke patients.
Research questions:
1) Does an 8 week technology-assisted task-oriented training program improve
arm-hand function/activity and quality of life in persons who are in a chronic
phase after stroke?
2) Does an 8 week technology-assisted task-oriented training program improve
arm- hand function/activity and quality of life in persons who are in a chronic
phase after stroke relative to task oriented training that is not supported by
technology?
3) Does the treatment effect of task oriented training lasts longer after
technology supported task oriented training relative to task oriented training
without technology support in persons who are in a chronic stage after stroke?
4) Is treatment compliance during an 8 week technology-assisted task-oriented
training program higher than during an 8 week task-oriented training program
without technology support in persons who are in chronic phase after a stroke?
Study design
The TEST-TRACS study is a multi-centre, single-blinded, randomized controlled
clinical trial in which an 8 weeks TOAT training, assisted by technology (ULTRA
system), is contrasted to TOAT without technology-support from ULTRA.
Average scores and SD scores of the ULTRA kinematic data, the Fugl-Meyer test
data and ARA(T) data will be calculated for T0, T1, T2 and T3. Statistical
analysis of these data will include repeated measurement AN(C)OVA (multiple
comparison), regression analysis, GEE.
The data of MAL, SF-36, EuroQol and other questionnaires will be reported
descriptively.
Time schedule:
- training of therapists: Jun 08 - Oct 08
- identification of participants: Oct 08 - Oct 09
- inclusion time: Nov 08 - Oct 09
- data collection: Nov 08 - Apr 10
- data-analysis: Nov 09 - May 10
- reporting: Apr 10 - Jun 10
Intervention
Eighty four persons in chronic stage after stroke will train for 8 weeks, 4
days per week, 2x 30minutes per day on minimum two skills (listed above).
Hereby half of them will only be supported by DVD/video-instruction; the other
half will be supported by Philips Rehabilitation Exerciser (ULTRA). Following
parameters will be registred:
- kinematics of arm and trunk
- Fugl-Meyer Test
- Action Research Arm Test
- Motor Activity Log
- SF-36
- EuroQol
- Goal Attainment Scaling
- Diary Compliance Log
Average scores and SD scores of the ULTRA kinematic data, the Fugl-Meyer test
data and ARA(T) data will be calculated for T0, T1, T2 and T3. Statistical
analysis of these data will include repeated measurement AN(C)OVA (multiple
comparison), regression analysis, GEE.
The data of MAL, SF-36, EuroQol and other questionnaires will be reported
descriptively.
Study burden and risks
The risk involved in this study is minimal and does not exceed the risks
associated with general daily activities.
Weisshausstrasse 2
D-52066 Aachen
Germany
Weisshausstrasse 2
D-52066 Aachen
Germany
Listed location countries
Age
Inclusion criteria
- first ever supratentorial stroke
- 18-85 years old
- clinically diagnosed as having a central paresis of the arm/hand (strength Medical Research Council grade 2-3-4 at entry into the study)
- post-stroke time >=12 months
- fair-good cognitive level: MMSE (score above 26) or CogLog (score above 26)
- ability to read
- ability to understand Dutch language
- persons have to be impaired for 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.
- Motivated to train on above mentioned skills
Exclusion criteria
- severe neglect:
• From medical files persons are selected that perform well on the O-zoek test: difference between omissions right and left >= 2 will not be included. This test is not validated, but is used in SRL and checking on its result will help us contacting persons that are appropriate to be included in this study.
• Letter cancellation test and bell*s test (only part of quantitative evaluation) to ensure that no severe neglect is present. These tests assess neglect in near extrapersonal space. The omission score is calculated. A minimum omission score of 15% is considered to indicate unilateral spatial neglect (USN) in cancellation testing. Ferber and Karnath (2001) found that each of the latter tests only miss 6% of the neglect patients which is acceptable for this study.
- hemianopsia: retrieved from medical patient file
- severe spasticity: Modified Ashworth Scale total arm >4
- severe additional neurological, orthopaedic or rheumatoid impairments prior to stroke that may interfere with task performance
- Broca aphasia, Wernicke aphasia, global aphasia: as determined by Akense Afasie Test (AAT) (information obtained from medical files)
- severe apraxia: apraxietest van Heugten (information from medical files)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN82787126 |
| CCMO | NL23303.022.08 |