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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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