Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke

Recruiting

Phase 1/2 Results N/A

Trial Description

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.

Detailed Description

As above

Conditions

Interventions

  • H-Man Device
    Other Names: No other names.
    Intervention Desc: H-man is a portable end-effector planar upper limb robot.
    ARM 1: Kind: Experimental
    Label: H-Man
    Description: H-Man is a novel, portable, inexpensive end-effector upper limb robot.
  • Additional Conventional Therapy Other
    Other Names: No other names
    Intervention Desc: Repetitive goals based arm therapy
    ARM 1: Kind: Experimental
    Label: Additional Conventional Therapy
    Description: Repetitive goals based arm therapy

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in Fugl Meyer Assessment of Motor Recovery 0, 3, 6, 12 and 24 weeks after start of intervention No
Secondary Change from Baseline in Action Research Arm Test 0, 3, 6, 12 and 24 weeks after start of intervention No

Sponsors