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

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: March 31, 2018

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

Singapore

Tan Tock Seng Rehabilitation Centre

Singapore, Singapore, 569766

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

More Information

• Responsible Party: Chua Sui Geok, Karen, Senior Consultant, Tan Tock Seng Hospital
• ClinicalTrials.gov Identifier: NCT02188628
• Other Study ID Numbers: 2014/00122
• First Posted: July 11, 2014
• Last Update Posted: September 12, 2019
• Last Verified: September 2019

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