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

• ClinicalTrials.gov Identifier: NCT02188628
• Recruitment Status: Completed
• First Posted: July 11, 2014
• Last Update Posted: September 12, 2019
• Sponsor: Tan Tock Seng Hospital
• Collaborator: National Medical Research Council (NMRC), Singapore
• Information provided by (Responsible Party): Chua Sui Geok, Karen, Tan Tock Seng Hospital

Tracking Information

• First Submitted Date: July 2, 2014
• First Posted Date: July 11, 2014
• Last Update Posted Date: September 12, 2019
• Actual Study Start Date: July 1, 2014
• Actual Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 9, 2014)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 9, 2014)

Change from Baseline in Action Research Arm Test [ Time Frame: 0, 3, 6, 12 and 24 weeks after start of intervention ]

As above

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
• Official Title: Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke

Brief Summary

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
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
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.

Primary Purpose: Other

• Condition: Stroke

Intervention

• Device: H-Man
  H-man is a portable end-effector planar upper limb robot.
  Other Name: No other names.
• Other: Additional Conventional Therapy
  Repetitive goals based arm therapy
  Other Name: No other names

Study Arms

• Experimental: H-Man
  H-Man is a novel, portable, inexpensive end-effector upper limb robot.
  Intervention: Device: H-Man
• Active Comparator: Additional Conventional Therapy
  Repetitive goals based arm therapy
  Intervention: Other: Additional Conventional Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 17, 2017): 44
• Original Estimated Enrollment (submitted: July 9, 2014): 60
• Actual Study Completion Date: March 31, 2018
• Actual Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging
• Duration post stroke: 3 months to 24 months
• Age 21 to 85 years
• Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power >/= 3/5 and elbow flexion MRC motor power >/= 3/5
• Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50
• And / or associated motor incoordination or motor ataxia

Exclusion Criteria:

• Non stroke related causes of arm motor impairment
• Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage renal failure, terminal malignancy), life expectancy <6 months, unhealed fractures or severe arm pain (visual analogue scale VAS > 5/10, pregnancy
• Inability to tolerate sitting for 90 minutes.
• Local factors which preclude robotic interfacing or may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain VAS >5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with interface with the H-man robot.
• Severe sensory impairment of affected limb
• Severe visual impairment, hemispatial neglect or homonymous hemianopia
• Cognitive impairments or uncontrolled behaviour. (Folstein mini mental state exam MMSE <26/28)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT02188628
• Other Study ID Numbers: 2014/00122
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Chua Sui Geok, Karen, Tan Tock Seng Hospital
• Study Sponsor: Tan Tock Seng Hospital
• Collaborators: National Medical Research Council (NMRC), Singapore

Investigators

• Principal Investigator: Chua SG Sui Geok, MBBS,FRCP; Tan Tock Seng Hospital

• PRS Account: Tan Tock Seng Hospital
• Verification Date: September 2019