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

Stroke Clinical Trial

Official title:

Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188628
• Other study ID #: 2014/00122
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2019
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• H-Man
H-man is a portable end-effector planar upper limb robot.

Other:
• Additional Conventional Therapy
Repetitive goals based arm therapy

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Rehabilitation Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Fugl Meyer Assessment of Motor Recovery	As above	0, 3, 6, 12 and 24 weeks after start of intervention
Secondary	Change from Baseline in Action Research Arm Test	As above	0, 3, 6, 12 and 24 weeks after start of intervention