An interventional study of Robotic and Conventional therapy in Stroke, sponsored by Ten-Chen General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-09-13.
Sponsored by Ten-Chen General Hospital · Not applicable, Interventional, and Treatment
The effectiveness of robotic over conventional therapy is arguable and the best therapy strategy is still not clear. Basing on the existing evidence on motor learning and practice-induced neuroplasticity, the investigators plan to use an exoskeleton robotic hand to enhance the rehabilitation volume in the subacute stage of stroke patients. The robotic system allows intensive and customized training of hand and finger movements. The aim of this study is (1) to establish whether robot assisted therapy provides any additional motor recovery for the hand when administered during the subacute stage in a Chinese adult population diagnosed with stroke; (2) to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic patients.
Introduction The number of incident strokes, prevalent stroke survivors, disability-adjusted life-years (DALYs) lost due to stroke, and stroke-related deaths is increasing in the word (1). Stroke is the most common cause of complex disability in Taiwan (2). After the acute phase of stroke, many patients are left with impairment of upper-limb movement (hemiparesis) because of the hand weakness and abnormal contractions. Motor recovery of the hand is the slowest and most difficult, leading to limited hand activities and occupational disability. Therefore, facilitating motor recovery of hand after stroke is crucial in stroke rehabilitation.
The mechanisms of recovery after stroke are multifactorial and the effect of rehabilitation programs is complex (3). Activity-dependent neural plasticity of the cortical maps adjacent to the lesion probably occurs, particularly during the acute period after stroke (4). In order to stimulate such plasticity, many new rehabilitation methods, including rehabilitation robots, have been developed according to the principles of motor learning (5). Robotic systems can provide repetitive, reproducible, interactive forms of physical therapy that can be quantified (6). The advantages of using robots in neuromotor rehabilitation includes favoring attention and reducing the effort of the patient during training (7), boosting motivation and adherence to treatment (8), as well as help in multi-sensory and sensorimotor integration (9). Some results are very promising, showing that robot-assisted therapy is safe and well tolerated and that it has a positive impact on muscle strength and function in the paretic arm (10-12). However, the quality of these evidence is still controversial and inconclusive. The effectiveness of robotic over conventional therapy is arguable and the best therapy strategy is still not clear. Furthermore, there is little understanding of the neurological mechanisms involved in functional recovery of the hand (13). In this study, the investigators hypothesize that the robot based assistance would outperform conventional therapy during the subacute stage of stroke.
Study objective
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 34 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Ten-Chen General Hospital as lead sponsor.
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The experimental group will receive 30 minutes robotic training sessions, 3 times per week for a total of 30 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive schedule (1-hour sessions, 3 times/week, 30 total sessions) of conventional therapy from an occupational therapist.
Device: Robotic · Other: Conventional therapy
In conventional therapy group, participants will receive an one-hour of one-on-one treatment (1-hour sessions, 3 times/week, 30 total sessions) from an occupational therapist, focusing on arm and hand function.
Other: Conventional therapy
Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.
Also known as: Conventional therapy
An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.
Change in Fugl-Meyer score
The investigators used FMA scale to evaluate sensorimotor recovery of patients with particular attention to the hand and wrist section (maximum score=24) to assess the functional capacity of the affected hand.
Time frame: Change from baseline to 10 weeks
Change in Motricity Index (MI) scale
The Motricity Index was used to measure strength in upper and lower extremities after stroke. The weighted score based on the ordinal 6 point scale of Medical Research Council was used to measure maximal isometric muscle strength.
Time frame: Change from baseline to 10 weeks
Change in Functional Independence Measure scale (FIM)
The investigators used FIM to assess the degree of independence and need-of-assistance in basic activities of daily living at enrolment and at the end of the study. FIM is an 18-item ordinal scale rated from 1 (total dependence) to 7 (total independence) per item; 13 items of this scale, the sub-scale Motor- FIM, were used to evaluate motor disability.
Time frame: Change from baseline to 10 weeks
Change in Visual analogue scale (VAS)
The investigators used VAS (0 extremely simple- 10 extremely difficult) to access the feasibility of the device in terms of the number of patients who completed the program.
Time frame: Change from baseline to 10 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Nov 2017 to primary completion in Jun 2019, 18 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 18 months is below that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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