Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke

NCT02188628 | Completed

• 1 other identifier: 2014/00122
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Motor recovery, robotics, stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Fugl Meyer Assessment of Motor Recovery

  As above

  0, 3, 6, 12 and 24 weeks after start of intervention

Secondary Outcomes (1)

• Change from Baseline in Action Research Arm Test

  0, 3, 6, 12 and 24 weeks after start of intervention

Study Arms (2)

H-Man

EXPERIMENTAL

H-Man is a novel, portable, inexpensive end-effector upper limb robot.

Device: H-Man

Additional Conventional Therapy

ACTIVE COMPARATOR

Repetitive goals based arm therapy

Other: Additional Conventional Therapy

Interventions

H-Man DEVICE

H-man is a portable end-effector planar upper limb robot.

Also known as: No other names.

H-Man

Additional Conventional Therapy OTHER

Repetitive goals based arm therapy

Also known as: No other names

Additional Conventional Therapy

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Tan Tock Seng Rehabilitation Centre

Singapore, 569766, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34149587 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chua SG Sui Geok, MBBS,FRCP

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded therapist assessor to determine clinical outcomes at pre and post treatment and follow up.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: H-Man training + conventional therapy vs equal amount of conventional therapy 1:1 allocation

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)