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 *: Budhota A, Chua KSG, Hussain A, Kager S, Cherpin A, Contu S, Vishwanath D, Kuah CWK, Ng CY, Yam LHL, Loh YJ, Rajeswaran DK, Xiang L, Burdet E, Campolo D. Robotic Assisted Upper Limb Training Post Stroke: A Randomized Control Trial Using Combinatory Approach Toward Reducing Workforce Demands. Front Neurol. 2021 Jun 2;12:622014. doi: 10.3389/fneur.2021.622014. eCollection 2021.

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