Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
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|ClinicalTrials.gov Identifier: NCT02188628|
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : September 12, 2019
Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require specialized rehabilitation. In recent years, robot-aided therapy has been proposed as a means of complementing traditional therapy to alleviate the burden on therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots have been proposed in the literature but only half a dozen have been commercialized and typically none are seen in local clinics, due to exceedingly high costs. A novel, compact, inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for experiments in motor control neuroscience. The H-man can generate computer-controlled force fields to assist or resist a subject's motion and is potentially an optimal trade-off between clinical efficacy and robotic complexity. A first prototype of the H-Man is available at NTU.The primary aim of this proposed project is to assess to what extent the investigators H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design involving stroke survivors. The investigators believe that H-Man can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU engineers, a portable version of the H-Man will be developed which will be tested in a 12 subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT) study. At the same time, the feasibility of H-Man integration for a pared down home use model will be assessed in 4 subjects.
The investigators primary hypothesis is that sub-acute/chronic patients will exhibit clinically significant decreases of impairment when training with the H-Man combined with standard arm therapy on robot-measured scales and standardized clinical scales, at the level of elbow/shoulder after 18 sessions of training on the H-Man.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: H-Man Other: Additional Conventional Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blinded therapist assessor to determine clinical outcomes at pre and post treatment and follow up.|
|Official Title:||Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke|
|Actual Study Start Date :||July 1, 2014|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||March 31, 2018|
H-Man is a novel, portable, inexpensive end-effector upper limb robot.
H-man is a portable end-effector planar upper limb robot.
Other Name: No other names.
Active Comparator: Additional Conventional Therapy
Repetitive goals based arm therapy
Other: Additional Conventional Therapy
Repetitive goals based arm therapy
Other Name: No other names
- Change from Baseline in Fugl Meyer Assessment of Motor Recovery [ Time Frame: 0, 3, 6, 12 and 24 weeks after start of intervention ]As above
- Change from Baseline in Action Research Arm Test [ Time Frame: 0, 3, 6, 12 and 24 weeks after start of intervention ]As above
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188628
|Tan Tock Seng Rehabilitation Centre|
|Singapore, Singapore, 569766|
|Principal Investigator:||Chua SG Sui Geok, MBBS,FRCP||Tan Tock Seng Hospital|