The objective of this study is to determine whether arm function changes after active-movement stimulating (ACTS) training and if so, which mechanisms (neurophysiologic, biomechanic and/or functional domains) are influenced by ACTS training.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are intra-subject changes in muscle activity and
biomechanics of arm movements (at the impairment level).
Secondary outcome
The Fugl-Meyer assessment, the Motricity Index (both are clinical scores of the
motor status of the arm) and the Action Research Arm Test (for functional
abilities of the arm) are included to examine changes at the functional level.
Background summary
Active generation, and initiation, of movement is a very important aspect of
post-stroke arm training, since active movements produce more brain activation
and better motor learning than passive movements, in which the arm is guided.
To enable active use of the arm, supporting the weight of the arm using 3D
gravity compensation during reach and retrieval movements is beneficial. In
addition, providing feedback by emphasising movement error may be helpful by
stimulating patients to generate more appropriate movement patterns.
Integration of these aspects into a new training protocol, using a robotic
device to provide feedback about undesired movements, may provide a
rehabilitation application to enhance restoration of arm function after stroke.
Study objective
The objective of this study is to determine whether arm function changes after
active-movement stimulating (ACTS) training and if so, which mechanisms
(neurophysiologic, biomechanic and/or functional domains) are influenced by
ACTS training.
Study design
A multiple baseline design is used to examine whether individual changes in arm
function occur after ACTS training, by pre- and post-training measurements of
neurophysiologic, biomechanic and functional aspects of upper extremity
movement.
Intervention
The intervention consists of a training program of 6 weeks of upper extremity
training of reaching and grasping exercises, supplemented to (potential)
regular stroke rehabilitation. Training sessions take place 3 times per week
for 60 minutes. Unwanted (abnormal) movements are opposed by robotic device to
provide additional feedback.
Study burden and risks
The burden and the risks for participants are limited to a minimal extent,
since the movement tasks consist of functional and familiar arm movements,
performed only within the abilities and reach of the participants. Furthermore,
the robotic device used to provide feedback about unwanted movements is
designed in such a way that movements can not be performed outside the
participants* abilities, since the device can only resist movements that the
participants generate themselves and can not move the arm of participants by
itself.
Participation of patients in this experiment may have a direct benefit for
them, in that they receive an additional amount of therapy besides their
(potential) regular rehabilitation programme, which has been reported to be
beneficial for post-stroke rehabilitation. However, since the study purpose is
to investigate whether this type of training induces changes in arm function,
this improvement in arm function can not be guaranteed.
Roessingsbleekweg 33b
7522 AH Enschede
Nederland
Roessingsbleekweg 33b
7522 AH Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Stroke at least 6 months prior to admittance to experiment
Right upper extremity affected (experimental set-up only suitable for right arm)
Receiving/having received treatment at the Roessingh Centre of Rehabilitation
Ability to lift arm (partly) against gravity
Exclusion criteria
Shoulder pain, either in rest or in movement
Additional neurologic, orthopaedic or rheumatologic disease of right upper extremity, which is likely to interfere with mobility and/or strenght of the arm
Inability to understand and follow instructions
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 | NL16576.080.07 |