The primary objective of this study is to examine user acceptance and assess changes in arm function by people with chronic stroke following technology-supported arm/hand training at home. Secondary objectives are to examine whether stroke patients…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are outcomes related to user acceptance, including
usability, satisfaction, motivation and compliance (Intrinsic Motivation
Inventory, System Usability Scale, Qualitative interview about experience of
use).
Secondary outcome
Measures to examine general motor function, perceived use and participation
(The Action Research Arm Test (ARAT), the upper extremity part of the
Fugl-Meyer (FM) test, the Box & Blocks test (BBT), Motor Activity Log (MAL),
the Stroke Impact Scale (SIS), kinematics and EMG).
Background summary
After experiencing a stroke, the majority of people have to cope with impaired
arm and hand function. Post-stroke rehabilitation training aims to regain arm
and hand motor function, which is essential to perform most activities of daily
living (ADL) independently. To stimulate restoration of arm function after
stroke, intensive, task-specific training with active contribution of the
patient is essential. The application of robotics in rehabilitation to promote
this repetitive training is promising. Most research involving robotics so far
has demonstrated significant improvement in upper limb motor function by
participants, but limited studies have showed improvements in ADL. In the
SCRIPT project we are developing robotic technologies for home rehabilitation
to enable self-administration of more intense and more frequent exercises,
specifically of the hand and wrist with the goal of contributing to the
personal independence of stroke patients.
Study objective
The primary objective of this study is to examine user acceptance and assess
changes in arm function by people with chronic stroke following
technology-supported arm/hand training at home.
Secondary objectives are to examine whether stroke patients increase their
total amount of practice when provided with the opportunity, examine if this
additional training enhances changes in arm/hand function and explore which
factors contribute to this. We also intend to examine whether
technology-supported arm/hand training at home results in comparable
improvements to that observed after conventional training.
Study design
This explorative feasibility study has a longitudinal design with an
experimental group and a control group. Evaluation is based on one baseline
measurement pre-training and two evaluation measurements post-training (within
one week and follow-up after two months).
Intervention
During six weeks, the chronic stroke patients will receive either 18 one hour
sessions, plus additional training when desired, of technology assisted arm and
hand home training (experimental group), or conventional home training (control
group). For the experimental group, training consists of arm and hand exercises
conducted while undertaking computerised games, wearing the SCRIPT hand device
to support hand opening, and wearing the SaeboMAS for gravity compensation of
the proximal arm. The training for the control group consists of standard arm
and hand exercises.
Study burden and risks
Participation in this study can provide an immediate benefit for the subject,
in providing the opportunity for additional, self directed rehabilitation of
the affected arm and hand. The extent of this benefit cannot be predicted,
obtaining these insights is one of the purposes of this study.
The risks for the subjects are minimum, since the movement tasks consist of
functional and familiar arm and hand movements and are performed within the
ability of the subject, while he/she is seated. Subjects in the experimental
groups will wear a fully passive device with only springs. This is an
inherently safe device because the subject cannot be forced into a position
he/she cannot achieve by him/herself. The recommended training sessions will be
spread throughout the week to minimise the burden for the subjects. Besides,
the subjects will be monitored by a HCP for signs of overloading. This will be
based on questions on pain, fatigue, motivation etc. asked after each training
session. In addition, the outcome measurements used in this study during the
evaluation measurements (movement analysis, functional scales) are all
non-invasive and involve no risk for the subjects.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
• Patients with an unilateral ischemic or hemorrhagic stroke, between 6 months and 5 years post-stroke
• Between 18 and 80 years of age
• Clinically diagnosed with central paresis of the arm and/or hand as a result of stroke, but with:
- 15° active elbow flexion
- * range of active finger flexion (PIP/DIP)
• Ability to complete measurements and training sessions
• Discharged from medical centre
• Living at home and have internet access
• Having a carer who is co-resident or closely involved in their care
• A fair cognitive level: ability to read and understand the Dutch language, and ability to understand and follow instructions
• Patients should fit the device: 5-95% size of hand and body shape
• Written informed consent to participate in the study.
Exclusion criteria
• Patients who are not eligible to join normal rehabilitation (psychological issues, patients with near complete paralysis etc.)
• Other severe co-morbidities, like cardiovascular, neurological, orthopaedic or rheumatoid impairments (incl. pain affecting use of the upper extremity) before stroke that may interfere with task performance
• Severe sensory deficits from the involved limb
• Severe neglect
• Visual impairments (that cannot be corrected with glasses or contact lenses to within normal or near normal limits)
• Cognitive impairments
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL42483.044.12 |