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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 : Recruiting
First Posted : July 11, 2014
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Chua Sui Geok, Karen, Tan Tock Seng Hospital

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.


Condition or disease Intervention/treatment Phase
Stroke Device: H-Man Other: Additional Conventional Therapy Not Applicable

Detailed Description:
As above

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
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
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: H-Man
H-Man is a novel, portable, inexpensive end-effector upper limb robot.
Device: H-Man
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from Baseline in Action Research Arm Test [ Time Frame: 0, 3, 6, 12 and 24 weeks after start of intervention ]
    As above



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
Contact: Chua SG Sui Geok, MBBS, FRCP 6568894580 karen_chua@ttsh.com.sg
Contact: Lester J Yam, MBBS, MRCP 6568894580 Lester_HL_Yam@ttsh.com.sg

Locations
Singapore
Tan Tock Seng Rehabilitation Centre Recruiting
Singapore, Singapore, 569766
Contact: Chua SG Sui Geok    6564506165    karen_chua@ttsh.com.sg   
Principal Investigator: Chua SG Sui Geok         
Sub-Investigator: Loh YJ Yong Joo         
Sub-Investigator: Deshan K Kumar         
Tan Tock Seng Rehabilitation Centre Recruiting
Singapore, Singapore, 569766
Principal Investigator: Chua Sui Geok Karen, MBBS, FRCP         
Sponsors and Collaborators
Tan Tock Seng Hospital
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Chua SG Sui Geok, MBBS,FRCP Tan Tock Seng Hospital

Responsible Party: Chua Sui Geok, Karen, Senior Consultant, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT02188628     History of Changes
Other Study ID Numbers: 2014/00122
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chua Sui Geok, Karen, Tan Tock Seng Hospital:
Motor recovery, robotics, stroke rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases