Robotic Therapy Early After Stroke Events

NCT01552733 | Completed

• 2 other identifiers: GN12MT023R12/A141
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Weakness and impairment of the upper limb is a common contributing factor to post stroke disability. Specially designed robotic systems have been developed to try to improve this. The investigators already know that their use helps improve limb function after stroke when it has been present for many months. The investigators do not know whether they can help early after stroke and enhance recovery of limb function, and perhaps prevent weakness becoming chronic. The investigators plan a randomised controlled blinded study to explore the benefits of robot assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised by 7 days after stroke to standard care or to robotic therapy (40 participants per study group). Standard of care will be rehabilitation therapy according to local guidelines delivered by NHS multidisciplinary team. Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a series of taks including circle-drawing, reaching targets and holding/moving against moderate resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be delivered. This study will take 3 years to complete.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer score therapy.

  One month

• Feasibility

  Defined as the proportion of individuals randomised to robotic intervention who complete 12 sessions of Robotic therapy. Will serve as a coprimary endpoint.

  One month

Secondary Outcomes (6)

• Fugl-Meyer score.

  Day 90

• Modified Rankin scale score

  DAy 90

• Barthel index

  Day 90

• Stroke Impact Scale

  Day 90

• NIHSS

  Day 90

Study Arms (2)

Robotic Therapy

EXPERIMENTAL

Robotic Therapy using 'Inmotion' device plus standard care. Participants randomised to robotic therapy will receive up to 12 sessions (approximately 1 hour each) performing tasks (including circle drawing, reaching targets and holding/moving against moderate resistance.

Device: 'Inmotion Arm Robot'

Standard Care

PLACEBO COMPARATOR

Rehabilitation therapy according to local guidelines.

Other: Standard of care

Interventions

'Inmotion Arm Robot' DEVICE

To improve limb function in those with limb impairment

Robotic Therapy

Standard of care OTHER

Rehabilitation Therapy

Standard Care

Eligibility Criteria

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

You may qualify if:

• Aged \> 18 years
• Confirmed diagnosis of stroke
• Randomisation by seven days
• Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of \<50 at randomisation
• Able to comply with the requirements of the protocol

You may not qualify if:

• Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation.
• Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness.
• Participation in other stroke rehabilitation trial.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Western Infirmary, NHS Greater Glasgow and Clyde

Glasgow, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jesse Dawson, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Senior Lecturer in Medicine / Honorary Consultant

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: March 16, 2016
• Study Completion: March 16, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

GB (1)