Effects of a Provision of a Cane After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150979
• Other study ID #: FAPEMIG
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Provision of a cane
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.
• Control
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.

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy, Universidade Federal de Minas Gerais	Belo Horizonte	MG
Brazil	NeuroGroup Laboratory	Belo Horizonte	MG

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)