Exoskeleton for Post-Stroke Recovery of Ambulation

Conditions Clinical Trial

— ExStRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995265
• Other study ID #: H15-01339
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 30, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conditions
• Stroke

Intervention

Device:
• Exoskeleton Program
Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.

Other:
• Usual Care Program
Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.

Locations

Country	Name	City	State
Canada	Glenrose Rehabilitation hospital	Edmonton	Alberta
Canada	Parkwood Institute	London	Ontario
Canada	GF Strong Rehab Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking ability - Functional Ambulation Category		Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
Secondary	5-Metre Walk Test (5MWT)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	6-Minute Walk Test (6MWT)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	Berg Balance Scale (BBS)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	Health-related Quality of Life (SF-36)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	Depressive Symptoms (PHQ-9)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	Days to independent walking	The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded.	Discharge (generally 4-6 weeks, up to 8 weeks)
Secondary	Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	Cognition - Montreal Cognitive Assessment (MoCA)		Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Secondary	Functional Ambulation Category		6 Months from admission
Secondary	Daily step count	ActivPAL recording over 4 days	6 months from admission