Recruiting

RESTORE

Sponsor:

University of Calgary

Code:

NCT04201613

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Robotic exoskeleton

Usual Care

Study Details

Brief summary:

The purpose of this study is to investigate two aspects of robotic therapy after stroke. One goal is to determine if early robotic rehabilitation of the upper limb (beginning 5-9 days post-stroke) is more effective than later robotic rehabilitation (beginning 21-25 days post-stroke). The other goal is to determine if higher intensity robotic rehabilitation (2 hours/day) is more effective than lower intensity robotic rehabilitation (1 hour/day).

Conditions

Stroke

Study ID

NCT04201613

Start date

May 1, 2019

Status verified date

Dec, 2019

Completion date

Oct, 2023

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recent first stroke (ischemic or hemorrhagic)
  • Upper extremity Fugl-Meyer score 15-45
  • Modified Ashworth score of shoulder/elbow less than or equal to 2
  • Able to follow task instructions
  • Visual acuity better than 20/50 in both eyes
  • Able to give consent
  • Able to commit to follow-up

Exclusion Criteria:

  • Prior stroke or significant neurologic problem (e.g. Multiple Sclerosis)
  • Pre-existing musculoskeletal injury that will interfere with active therapy
  • Pre-Stroke Modified Rankin Score > 2
  • Clinical evidence of Unilateral Spatial Neglect on the Behavioural Inattention Test (BIT)
  • Enrollment in a concurrent clinical intervention trial
  • Major co-morbid or concurrent illness such that improvement is unlikely or completion of the protocol as specified is unlikely

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Early Robotic Rehab Low Intensity

This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive one hour of treatment per day for 20 days.

active comparator: Early Robotic Rehab High Intensity

This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.

active comparator: Late Robotic Rehab Low Intensity

This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive one hour of treatment per day for 20 days.

active comparator: Late Robotic Rehab High Intensity

This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.

active comparator: Control Group

This group will receive usual care with robotic assessment.

Interventions

Robotic exoskeleton

The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.

Usual Care

This group will receive standard care with no additional therapy.

Primary outcome measure

  • Change in Fugl-Meyer upper extremity motor function score (FMA) [ Time Frame: From baseline to 44 days ]

Central Contacts and Locations

Central contacts

Mark Piitz, BSc

403-944-4050mark.piitz@albertahealthservices.ca

Locations

Foothills Hospital

Recruiting

Calgary, Alberta, Canada, T2N2T9

Contacts

Sean Dukelow, MD PhD

4039445930spdukelo@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Dec 23, 2019

Last verified

Dec, 2019

Keywords

  • Stroke
  • Stroke Rehabilitation
  • Robotic Exoskeleton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2019-12-23.