|- candidate number||8734|
|- NTR Number||NTR2638|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2010|
|- Secondary IDs||NL34868.044.10 CCMO|
|- Public Title||Electrical stimulation for post stroke hand opening.|
|- Scientific Title||Design and evaluation of multichannel stimulation algorithms to support hand opening during functional reach-to-grasp movements in stroke patients.|
|- hypothesis||Application of multichannel electrical stimulation on the wrist extensor, finger extensor, thumb abductor and thumb extensor will instanteneously increase functional handopening of stroke patients.|
|- Healt Condition(s) or Problem(s) studied||Stroke|
|- Inclusion criteria||1. A history of a single unilateral stroke in the medial cerebral artery (MCA) region resulting in single-sided hemiparesis;|
2. The onset of the stroke was more than six weeks ago;
3. The ability to voluntarily generate 20 degrees excursions in the plane of elevation (horizontal ab-/adduction) and elevation angle (ab-/adduction, ante-/retroflexion) of the shoulder joint;
4. The ability to voluntarily generate an excursion of 20 degrees of elbow flexion/extension;
5. The ability to voluntarily extend the wrist 10 degrees from neutral flexion/extension;
6. Adequate cognitive function to understand the experiments, follow instructions, and give feedback to the researchers.
|- Exclusion criteria||1. A fixed contracture deformity in the (affected) upper limb was present;|
2. Pain as a limiting factor for the subject's active range of motion;
3. The use of a pace-maker.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||31-jan-2012|
|- Target number of participants||40|
|- Interventions||Patients will receive different types of single and multichannel electrical stimulation. The instantaneous influence on functional hand opening of these types of electrical stimulation is addressed by the Box and Block Test.|
|- Primary outcome||The primary outcome of the present experiment is the Box and Block test which measures hand function of stroke patients. This functional measure is used to evaluate the influence of different types of electrical stimulation (EMG triggered and position triggered multichannel ES, single channel ES and none) on functional hand opening. |
|- Secondary outcome||Secondary study parameters are muscle activation patterns (MAP) measured with electromyography and kinematics during reach-to-grasp movements. |
|- Timepoints||The experiment consist of two measurements, spaced approximately three months apart.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Thijs Krabben|
|- CONTACT for SCIENTIFIC QUERIES|| Thijs Krabben|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|Euregio European Union (Interreg IV A)|
|- Brief summary||Rationale:|
The majority of stroke patients have to cope with impaired arm and hand function after a stroke. Post stroke rehabilitation training aims to regain (partly) lost functions by stimulation of restoration or promoting compensational strategies, in order to increase the level of independence. During rehabilitation training movements are practiced preferably with high intensity, in a task-oriented way, with an active contribution of the stroke survivor in a motivating environment. An effective training modality that is commonly applied in post stroke upper extremity rehabilitation training is arm support by means of gravity compensation. In order to increase functional abilities of the affected arm, hand function should also be trained. A promising technique to train hand function, or more specifically hand opening, after stroke is electrical stimulation of wrist and finger extensors and thumb abductors/extensors.
The primary objective of the present study is to study influence of different types of electrical stimulation on functional hand opening. The secondary objective of the study is to gain more insight in muscle activation patterns and kinematics during functional reach-to-grasp movements.
The study has a cross-sectional design, with one measurement session (T1) for healthy elderly and two sessions (T1 and T2, spaced approximately 3 months apart) for stroke patients.
20 healthy elderly and 20 stroke patients.
|- Main changes (audit trail)|
|- RECORD||5-dec-2010 - 11-mrt-2011|