Effects of a Provision of a Cane After Stroke

NCT ID: NCT03150979

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Provision of a cane

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.

Group Type: EXPERIMENTAL

Provision of a cane

Intervention Type: OTHER

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.

Group Type: OTHER

Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Luci Fuscaldi Teixeira-Salmela

Titular Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luci F Teixeira-Salmela, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Department of Physical Therapy, Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

NeuroGroup Laboratory

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

FAPEMIG

Identifier Type: -

Identifier Source: org_study_id