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Completed

NCT Number: NCT01552733

Robotic Therapy Early After Stroke Events

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Infirmary, NHS Greater Glasgow and Clyde

Glasgow, G11 6NT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

'Inmotion Arm Robot'

Device

To improve limb function in those with limb impairment

Standard of care

Other

Rehabilitation Therapy

Primary outcomes

  1. Fugl-Meyer score therapy.

    Time frame: One month

  2. Feasibility

    Time frame: One month

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

Secondary outcomes

  1. Fugl-Meyer score.

    Time frame: Day 90

  2. Modified Rankin scale score

    Time frame: DAy 90

  3. Barthel index

    Time frame: Day 90

  4. Stroke Impact Scale

    Time frame: Day 90

  5. NIHSS

    Time frame: Day 90

  6. Action Research Arm Test

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Acronym: R-TEASE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2012
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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