The aim of this study is to gauge the feasibility and potential order-of-magnitude the ReHab-TOAT concept may have on improving arm-hand skill performance in both subacute and chronic stroke patients. These data will be used to a) optimize the…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Action Research Arm Test (ARAT), gauging patients' arm hand skill capacity,
will serve as primary outcome measure in the pilot study.
Secondary outcome
The Fugl-Meyer test (gauging patients' fucntion level), the ABILHAND (gauging
patients' perceived skill performance), movement extent (measured by the remote
handling concept device) and self-perceived performance of activities trained
on by patients (gauged using a visual analogue scale (VAS)) will serve as
secundary outcome measures for the pilot study.
Background summary
One of the major deficits after a stroke is sensorimotor impairment in the
contralateral limb. A majority of these stroke patients has limited use of the
affected upper limb. One year after stroke, motor impairment of the upper limb
is associated with anxiety, lower perceived health-related quality of life and
a reduced subjective well-being. Improving arm-hand skill performance is a
major therapeutic target in stroke rehabilitation. However, treatment time and
financial resources are limited. In order to solve these problems, new
technology is being used to assist training of patients. By using
technology-assisted training, arm-hand function training and arm-hand skill
training may be augmented both in amount and duration of training as well as in
content richness / variety and task specificity, thus providing optimal
conditions for challenging the patient*s brain plasticity regarding
sensorimotor (re-)learning, yet, at the same time keep the workload for
(para-)medical staff and treatment costs manageable.
We developed a new task-oriented arm training approach using a so-called
*remote handling concept*, to manipulate proprioception, aiming at improvements
on the level of activities and participation. This approach is called *Remote
Handling concept based, Task-Oriented Arm Training* (acronym: ReHab-TOAT). We
hypothesize that, given the brain*s plasticity, proprioception manipulation
during task-oriented training may lead to improvements of arm-hand skill
performance in stroke patients.
Study objective
The aim of this study is to gauge the feasibility and potential
order-of-magnitude the ReHab-TOAT concept may have on improving arm-hand skill
performance in both subacute and chronic stroke patients. These data will be
used to a) optimize the training protocols and b) calculate the group sizes
needed in an envisioned larger RCT aimed at investigating the effectiveness of
ReHab-TOAT, that will be performed after this pilot study.
Also patients' experiences and therapists' experiences in using ReHab-TOAT will
be gauged, using questionnaires.
Study design
This study features a) a feasibility study, and b) a clinical pilot study
involvong subacute and chronic stroke patients.
In the feasibility study part, 5 patients will train with the ReHab-TOAT
concept in 2 therapy sessions. Also, 5 therapists will be involved in using the
ReHab-TOAT concept. Results may lead to further fine-tuning of the current
protocol and will be reported descriptively.
In the pilot study, featuring a (small) prospective cohort study design with
pre-post measurements, 5 subacute stroke patients and 5 chronic stroke patients
will receive ReHab-TOAT (additionally to therapy-as-usual, where applicable).
these data will serve as input for an estimation of the order-of-magnitude any
arm-hand skill performance improvement may have. These data will be used for a
group size calculation in a large RCT foreseen after this pilot study.
Intervention
Both the stroke patients in the chronic and in the subacute stage after stroke
will receive the so-called ReHab-TOAT (Remote Handling Based Task-Oriented Arm
Training). ReHab-TOAT contains task-oriented arm training for stroke patients
with a moderately to severely affected arm-hand in combination with haptic
feedback, generated by a remote handling device called DexterTM (Veolia Nuclear
Solutions UK, Didcot, UK). The task-oriented arm-training is based on the
T-TOAT method, developed and clinically evaluated in previous research
(TEST-TRACS study: CCMO dossier NL23303.022.08). With the haptic feedback
generated by the remote handling device, the researchers will manipulate
proprioception, especially during (daily) task/skill execution.
In the feasibility study part, 5 patients will train with the ReHab-TOAT
concept in 2 therapy sessions.
During the clinical pilot studies the patients will train for 6 weeks, 3x per
week, 1.5hr per day.
Study burden and risks
The risks associated with this study do not surpass the risks associated with
regular exercise training methods that are part of the patients regular
rehabilitation process. The skills to be performed are every day skills like
eating with knife and fork or combing one's hair. The remote handling device
may assist the execution of these daily skills by providing additional
proprioceptive information, i.e. information on the 'feeling of movement'. This
assistance is in the range of several grams to approx. 2-3 kilograms of force.
Restoring arm function (even if this is partial) is essential for a good
quality of life of stroke patients. The recovery mainly depends on proper
coordination of the intensity of the offered therapy on the patient*s capacity
to perform daily skills. The challenge in rehabilitation is to stimulate brain
plasticity in such a way that patients become more skilled. Key ingredients of
interventions that constitute such a reorganization are: task-specific,
goal-oriented and high-intensity of practice. Technology-assisted
rehabilitation offers the possibility to patients to train on improving their
daily skills in a motivating way for a longer time.
Zandbergsweg 111
Hoensbroek 6432CC
NL
Zandbergsweg 111
Hoensbroek 6432CC
NL
Listed location countries
Age
Inclusion criteria
Subacute stroke patients:
- An unilateral stroke (ischemic or haemorrhagic) confirmed by brain imaging;
- Post stroke duration between 6 weeks and 3 months;
- Hemiplegic pattern of arm motor impairment with UAT score 1-3;
- Age 18 years or more;
- Sufficient cognitive level, i.e. being able to understand the questionnaires
and measurement instructions.
Chronic stroke patients:
- An unilateral stroke (ischemic or haemorrhagic) confirmed by brain imaging;
- Post-stroke time larger than 12 months;
- Hemiplegic pattern of arm motor impairment with UAT score 1-3;
- Age 18 years or more;
- Sufficient cognitive level, i.e. being able to understand the questionnaires
and measurement instructions., Healthy subjects (i.e. therapists):
- degree in physiotherapy or occupational therapy;
- experience in treatment of patients with central nervous system deficits.
Exclusion criteria
Subacute and chronic stroke patients:
- Severe non-stroke related co-morbidity that may interfere with arm-hand
function.
- Additional complaints that may interfere with the execution of the
measurements.
- Severe cognitive problems that prevent the patient from understanding the
tasks
- Spasticity in the affected upper limb, i.e. a Modified Ashworth Scale (MAS)
score * 1+.
- No informed consent.
Healthy subjects (i.e. therapists):
- Therapists who are not willing to participate in this study.
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 |
|---|---|
| CCMO | NL70014.015.19 |