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Effects of a Provision of a Cane After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Provision of a cane
Control
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Assistive devices, Gait, Rehabilitation, Clinical trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physical Therapy, Universidade Federal de Minas Gerais
  • NeuroGroup Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Provision of a cane

Control

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Walking speed
Changes in walking speed, in m/s, assessed by the 10-m Walk Test.

Secondary Outcome Measures

Walking step length
Changes in walking step length, in meters, assessed by the 10-m Walk Test.
Walking cadence
Changes in walking cadence, in step/minutes, assessed by the 10-m Walk Test.
Walking capacity
Changes in walking capacity, in meters, assessed by the 6-min Walk Test.
Walking confidence
Changes in walking confidence, reported as scores ranging from 10 to 100, assessed by the Modified Gait Efficacy Scale.
Social Participation
Changes in social Participation, assessed by the Stroke Impact Scale (social participation sub-section).

Full Information

First Posted
May 9, 2017
Last Updated
March 24, 2020
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03150979
Brief Title
Effects of a Provision of a Cane After Stroke
Official Title
Effects of a Provision of a Cane on Locomotion and Social Participation of Individuals With Stroke: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Assistive devices, Gait, Rehabilitation, Clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-blinded, randomized, clinical trial.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provision of a cane
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Provision of a cane
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking speed
Description
Changes in walking speed, in m/s, assessed by the 10-m Walk Test.
Time Frame
Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Secondary Outcome Measure Information:
Title
Walking step length
Description
Changes in walking step length, in meters, assessed by the 10-m Walk Test.
Time Frame
Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Title
Walking cadence
Description
Changes in walking cadence, in step/minutes, assessed by the 10-m Walk Test.
Time Frame
Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Title
Walking capacity
Description
Changes in walking capacity, in meters, assessed by the 6-min Walk Test.
Time Frame
Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Title
Walking confidence
Description
Changes in walking confidence, reported as scores ranging from 10 to 100, assessed by the Modified Gait Efficacy Scale.
Time Frame
Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Title
Social Participation
Description
Changes in social Participation, assessed by the Stroke Impact Scale (social participation sub-section).
Time Frame
Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luci F Teixeira-Salmela, Ph.D.
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
Facility Name
NeuroGroup Laboratory
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Provision of a Cane After Stroke

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