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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
Sponsor:
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  ICMJE July 2, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE July 1, 2014
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Stroke
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2014)
60
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188628
Other Study ID Numbers  ICMJE 2014/00122
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chua Sui Geok, Karen, Tan Tock Seng Hospital
Study Sponsor  ICMJE Tan Tock Seng Hospital
Collaborators  ICMJE National Medical Research Council (NMRC), Singapore
Investigators  ICMJE
Principal Investigator: Chua SG Sui Geok, MBBS,FRCP Tan Tock Seng Hospital
PRS Account Tan Tock Seng Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP