Robotic Therapy Early After Stroke Events "R-TEASE"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Standard of care Drug
    Intervention Desc: Rehabilitation Therapy
    ARM 1: Kind: Experimental
    Label: Standard Care
    Description: Rehabilitation therapy according to local guidelines.
  • Inmotion Arm Robot Device
    Intervention Desc: To improve limb function in those with limb impairment
    ARM 1: Kind: Experimental
    Label: Robotic Therapy
    Description: 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 (inclusing circle drawing, reaching targets and holding/moving against moderate resistance.
  • 'Inmotion Arm Robot' Device
    Intervention Desc: To improve limb function in those with limb impairment
    ARM 1: Kind: Experimental
    Label: Robotic Therapy
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer score therapy. One month No
Primary Feasibility One month No
Secondary Fugl-Meyer score. Day 90 No
Secondary Modified Rankin scale score DAy 90 No
Secondary Barthel index Day 90 No
Secondary Stroke Impact Scale Day 90 No
Secondary NIHSS Day 90 No
Secondary Action Research Arm Test Day 90 No

Sponsors