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Completed

NCT Number: NCT02995265

Exoskeleton for Post-Stroke Recovery of Ambulation

To determine the effect of using a robotic exoskeleton to allow walking practice after stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary outcomes.

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Key information

Conditions

Conditions Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenrose Rehabilitation hospital, Edmonton, Alberta, Canada

Loading trial locations.

About this study

Participants admitted to inpatient stroke rehabilitation for physiotherapy services will be randomly assigned to either the Exoskeleton Program or Usual Care Program.

Individuals in the Exoskeleton Program will have their usual physiotherapy sessions replaced with the exoskeleton intervention. The exoskeleton will allow standing and walking from the first sessions in rehabilitation, as the exoskeleton provides the physical support to allow walking in full weight-bearing without being limited by therapist fatigue and lifting requirements. Individuals in the Usual Care Program will receive standard physiotherapy care, which is individualized and hands-on with their therapist to regain walking, mobility, and independent function.

Both groups will be conducted 3-5 days a week, 30-60 minutes per session until discharge (to a maximum of 8 weeks). Participants will be assessed at baseline, discharge, and 6-months after starting rehabilitation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have been admitted to a hospital unit for stroke treatment
  • Stroke within last 3 months
  • One-sided hemiparesis
  • 19 years or older
  • Requires 2-person assist to walk
  • Able to communicate and follow instructions
  • Prescribed to receive physiotherapy care

Exclusion criteria

  • Stroke of non-vascular origin (e.g. tumour, infection)
  • Significant musculoskeletal or other neurological condition
  • Co-morbidities that would preclude activity
  • Pregnant
  • Unable to walk prior to stroke
  • <60 inches or >74 inches in height
  • >220 pounds in weight
  • Joint contractures or spasticity that would limit safe use of the Ekso exoskeleton

Treatment and study plan

Exoskeleton Program

Device

Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.

Usual Care Program

Other

Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.

Primary outcomes

  1. Walking ability - Functional Ambulation Category

    Time frame: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)

Secondary outcomes

  1. 5-Metre Walk Test (5MWT)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  2. 6-Minute Walk Test (6MWT)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  3. Berg Balance Scale (BBS)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  4. Health-related Quality of Life (SF-36)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  5. Depressive Symptoms (PHQ-9)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  6. Days to independent walking

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks)

    The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded.

  7. Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  8. Cognition - Montreal Cognitive Assessment (MoCA)

    Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission

  9. Functional Ambulation Category

    Time frame: 6 Months from admission

  10. Daily step count

    Time frame: 6 months from admission

    ActivPAL recording over 4 days

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Heart and Stroke Foundation of Canada

Registry information

Official study title

Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2

Acronym: ExStRA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2016
Registry last updated
Aug 31, 2020

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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