Clinical trial NCT04265664: Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
Official title: Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Cerebral Infarction
Brain Diseases
Central Nervous System Diseases
Cerebral Vascular Disorder
Brain Ischemia
Brain Infarction
Cardiovascular Diseases
Infarction
Keywords: Telerehabilitation
Lower extremity
Stroke
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group, pre-post study design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the feasibility and effectiveness of a lower extremity telerehabilitation protocol with aims to improve lower extremity recovery among community-living stroke survivors across Canada.

Detailed description: Eighty percent of stroke survivors experience some form of motor impairment, such as loss or limitation of function in muscle control or movement, or mobility limitation. Regaining walking ability is a priority for most and is achieved in approximately 80%. Unfortunately, the occurrence of falling while walking is as high as 73% of all people who recover the ability to walk post-stroke, with falls often occurring within the first few months of returning home from rehabilitation. This highlights the challenges with transitioning to the community for continued post-stroke rehabilitation. Unfortunately, due to increasing demand on our healthcare and rehabilitation systems and limited service capacity, stroke survivors receive minimal to no follow-up rehabilitation after returning to community-living. As a result, it is common for stroke survivors to report unmet lower extremity rehabilitation needs, and thus ongoing walking/mobility impairment, balance issues, high incidence of falls, and difficulties participating in desired social roles.

The rapid growth in the use of the Internet and personal mobile technologies, including computers, smartphones, and tablets has opened up an array of possibilities through which patients can remotely access specialized health services, such as telerehabilitation supports, while in their homes and communities. The use of technologies to facilitate optimal rehabilitation and recovery after stroke is under-utilized in Canada, despite being highly recommended in Canadian stroke guidelines, and positive beliefs about its potential among people with stroke.

Objectives:

1. To examine the feasibility (e.g. safety, recruitment rate, retention rate, fidelity and adherence, burden) of a lower extremity telerehabilitation protocol among community-living stroke survivors
2. To estimate the size of effect of TRAIL on clinical outcomes of functional mobility, lower extremity strength and motor impairment, functional balance, quality of life, balance self-efficacy, and goal attainment among community-living stroke survivors

Hypotheses:

The investigators expect that the the telerehabilitation protocol will demonstrate sufficient feasibility to support a larger, multisite randomized controlled trial (RCT). The investigators also hypothesize that stroke survivors will improve in functional mobility, lower extremity strength and motor impairment, functional balance, quality of life, balance self-efficacy, and goal attainment following 4-weeks of telerehabilitation with a trained therapist

This feasibility study will use a single group, pre- post- study design trial.

Eligibility criteria: Inclusion Criteria:

* 19 year of age or older;
* Within 18 months of the most recent stroke;
* Hemiparesis of the lower extremity;
* Able to walk 10m without physical assistance;
* Able to tolerate 50 minutes of activity (including rest breaks, as needed);
* Have cognitive-communicative ability to participate as per clinical judgement
* Able to provide informed consent;

Exclusion Criteria:

* Currently receiving in- or outpatient rehabilitation;
* Living in long-term care;
* Severe vision or hearing loss;
* Other neurological conditions, e.g. Parkinson's disease;
* Presence of significant comorbidities (e.g. severe osteoarthritis), pain or other symptoms that significantly impact lower extremity function;
* Planned surgery that would preclude or affect participation in the protocol

Primary outcomes:
measure: Change from baseline Timed Up and Go (TUG) at 4 weeks
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Secondary outcomes:
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
measure: Activities-Specific Balance (ABC) Scale
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
measure: Tandem Stand
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
measure: Functional Reach
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
measure: modified virtual Fugl-Meyer Assessment
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
measure: 30 second Sit to Stand
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
measure: Goal Attainment Scale
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Other outcomes:
measure: Feasibility Indicator: Recruitment Rate
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Retention Rate
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Perceived Benefit of Telerehabilitation
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Treatment Fidelity
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Participant Burden
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Participant Burden 2
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Assessor Burden
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Therapist Burden
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Ease of Using Equipment
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Processing Time
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Incidence of Treatment-Emergent Adverse Events (Safety)
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Treatment Response
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Treatment Effect
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: McMaster University
name: Ada Tang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Brodie Sakakibara, PhD
role: PRINCIPAL_INVESTIGATOR
References: