Effects of a Provision of a Cane After Stroke

Study Overview
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Brief Summary
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Previous studies failed to determine the real effects of the provision of a walking cane after a stroke, mainly due to biases related to their methodological designs. In addition, there is no information on the carry-over effects of a cane to social participation. This study will test the hypothesis that the provision of a cane is effective in improving walking speed, step length, cadence, walking capacity, walking confidence, and participation of individuals with chronic stroke. For this prospective, single-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participant's height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary. The control group will be instructed to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. To ensure the level of attention similar to that of the participants in the experimental group, the individuals in the control group will also receive weekly phone calls. At baseline (Week 0), post intervention (Week 4), and one month after the cessation (Week 8) of the interventions, researchers blinded to group allocations will collect all outcome measures.

Detailed Description
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Rationale: Motor impairments after a stroke are disabling and interfere with the performance of daily activities, such as locomotion. Walking devices, such as a single cane, are usually prescribed to increase safety and improve gait ability. Previous studies failed to determine the real effects of the provision of a walking cane after a stroke, mainly due to biases related to their methodological designs. In addition, there is no information on the carry-over effects of a cane to social participation. Aim: This study will test the hypothesis that the provision of a cane is effective in improving walking speed, step length, cadence, walking capacity, walking confidence, and participation of individuals with chronic stroke. Design: For this prospective, single-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participant's height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary. The control group will be instructed to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. To ensure the level of attention similar to that of the participants in the experimental group, the individuals in the control group will also receive weekly phone calls. At baseline (Week 0), post intervention (Week 4), and one month after the cessation (Week 8) of the interventions, researchers blinded to group allocations will collect all outcome measures. Study outcomes: walking speed, step length, cadence, walking capacity, walking confidence, and participation.

Official Title
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Effects of a Provision of a Cane on Locomotion and Social Participation of Individuals With Stroke: a Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: Provision of a cane
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with stroke will be eligible if they are >6 months after the onset of their first stroke, >20 years of age, Able to walk at least 14 meters, independently, walk with a speed ≤0.8 m/s or less, and Are naïve to use any assistive device. Exclusion Criteria: Individuals with cognitive impairments, double hemiparesis, or any other non-stroke related conditions.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-blinded, randomized, clinical trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provision of a cane<br>The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participant's height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary. | Other: Provision of a cane<br>* The participants will receive a single-point cane and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary.<br>|
| Other: Control<br>The control group will be instructed to to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. They will also receive weekly phone calls, to ensure similar level of attention to that of the the participants in the experimental group. | Other: Control<br>* The control group will be instructed to to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. They will also receive weekly phone calls, to ensure similar level of attention to that of the the participants in the experimental group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed | Changes in walking speed, in m/s, assessed by the 10-m Walk Test. | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking step length | Changes in walking step length, in meters, assessed by the 10-m Walk Test. | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | 
| Walking cadence | Changes in walking cadence, in step/minutes, assessed by the 10-m Walk Test. | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | 
| Walking capacity | Changes in walking capacity, in meters, assessed by the 6-min Walk Test. | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | 
| Walking confidence | Changes in walking confidence, reported as scores ranging from 10 to 100, assessed by the Modified Gait Efficacy Scale. | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | 
| Social Participation | Changes in social Participation, assessed by the Stroke Impact Scale (social participation sub-section). | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Assistive devices, Gait, Rehabilitation, Clinical trial