Effects of a Provision of a Cane After Stroke

NCT03150979 | Completed

• 1 other identifier: FAPEMIG
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Stroke; Assistive devices; Gait; Rehabilitation; Clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Walking step length

  Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)

• Walking cadence

  Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)

• Walking capacity

  Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)

• Walking confidence

  Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)

• Social Participation

  Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)

Study Arms (2)

Provision of a cane

EXPERIMENTAL

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

Control

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.

Other: Control

Interventions

Provision of a cane 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.

Provision of a cane

Control 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.

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals with cognitive impairments, double hemiparesis, or any other non-stroke related conditions.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (2)

Department of Physical Therapy, Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

NeuroGroup Laboratory

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Canes

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Luci F Teixeira-Salmela, Ph.D.

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Model Details: Prospective, single-blinded, randomized, clinical trial.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: August 1, 2017
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)