The general aim of this single arm trial (Evans S. Clinical Trial Structures. J Exp Stroke Transl Med 2010, 3(1):8-18) will be to obtain preliminary evidence on the efficacy of an individualised, intensive 6-week technology-assisted training regime…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Wolf Motor Function Test,
ABILHAND,
Goal Attainment Scaling.
Secondary outcome
Motricity index,
plate tapping task,
active range of motion,
perceived strength,
perceived fatigue.
Background summary
Approx. 80% of acute stroke patients suffer from acute hemiparesis. Stroke
patients have not reached their full potential when they are discharged from
hospital. It is proven that extra training opportunities lead to further
improvement. To date, new training possibilities, such as robotic techniques
for rehabilitation, virtual reality training systems and tele-rehabilitation
are being developed to aid in the training of stroke patients.
Study objective
The general aim of this single arm trial (Evans S. Clinical Trial Structures. J
Exp Stroke Transl Med 2010, 3(1):8-18) will be to obtain preliminary evidence
on the efficacy of an individualised, intensive 6-week technology-assisted
training regime, featuring a robotics-based self-adapting arm training system
(I-TRAVLE) in a virtual context, focussed on improvement of arm function and
arm skill performance in chronic stroke patients with low to moderate proximal
(shoulder/arm) muscle strength.
Study design
single arm prospective cohort study
Intervention
Haptic feedback of the I-TRAVLE robot either supports or challenges the patient
to perform movements of the arm, thereby training motor control and
co-ordination of the affected arm. Also strength and endurance of arm muscle
use may be trained. The I-TRAVLE based training will last 6 weeks. Each week
participants will attend training sessions on 3 days, during which they will
train 2x 30 minutes, interspaced by at least half an hour to avoid (general)
fatigue and overuse.
Study burden and risks
The participants may potentially have direct benefit from the project, i.e. the
training may lead to functional improvement of the affected arm. However, this
training is still under development. All tests and exercises are pain free,
easy to perform, non-intrusive, and not high demanding. Subjects will have to
undergo an assessment via a movement protocol as well as clinical outcome
tests. In both cases the type of assessment does not differ from the normal
assessment at a rehabilitation centre. The training is assisted using a robotic
device called the Haptic Master (HM). The participant*s arm is attached to the
HM via a gimbal. The HM has a number of safety features to avoid overload on
the participant*s arm. Any potential risk for overload is minimised by a)
careful build-up of the training regime; b) regular check-ups; and c) checking
the participant*s status prior to the next training session.
Zandbergsweg 111
Hoensbroek 6432 CC
NL
Zandbergsweg 111
Hoensbroek 6432 CC
NL
Listed location countries
Age
Inclusion criteria
o Age ><= 18 years;
o Clinically diagnosed with a central paresis of the arm/hand at entry in the study, caused by a supratentorial stroke;
o Post-stroke time more than 6 months;
o Having completed their active clinical rehabilitation program
o Hemiparesis featuring a low to moderate proximal (shoulder and arm) muscle strength:
* Motricity Index shoulder/arm item: minimum score of 14 and maximum 25 (out of 33), corresponding to a maximum active shoulder abduction of up to 90 degrees without resistance;
and/or
* a minimum active shoulder anteflexion of 30 degrees and a maximum active range of motion of 120 degrees shoulder joint anteflexion which can actively be maintained for 10 seconds;
o a fair cognitive level, i.e. being able to understand the questionnaires and measurement instructions;
o ability to read and understand Dutch.
Exclusion criteria
o Severe spasticity of the arm, i.e. Modified Ashworth Scale (MAS) score for the elbow and wrist flexors: each * 3;
o Severe visual impairment and/or severe cognitive impairment which may interfere with the execution of the arm-hand tasks or the measurements;
o Severe neglect in the near extra personal space, established by the letter cancellation test and Bell*s test (quantitative evaluation) with a minimum omission score of 15%;
o Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test (AAT);
o Severe apraxia as measured by the apraxia test of van Heugten;
o no informed consent.
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 |
|---|---|
| Other | ClinicalTrials.gov: registratienummer volgt nog |
| CCMO | NL44523.068.13 |