Stroke
Conditions
Keywords
Stroke, Assistive devices, Gait, Rehabilitation, Clinical trial
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.
Interventions
OTHERProvision 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.
OTHERControl
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.
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Prospective, single-blinded, randomized, clinical trial.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking speed | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Changes in walking speed, in m/s, assessed by the 10-m Walk Test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking step length | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Changes in walking step length, in meters, assessed by the 10-m Walk Test. |
| Walking cadence | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Changes in walking cadence, in step/minutes, assessed by the 10-m Walk Test. |
| Walking capacity | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Changes in walking capacity, in meters, assessed by the 6-min Walk Test. |
| Walking confidence | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Changes in walking confidence, reported as scores ranging from 10 to 100, assessed by the Modified Gait Efficacy Scale. |
| Social Participation | Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Changes in social Participation, assessed by the Stroke Impact Scale (social participation sub-section). |
Countries
Brazil
Outcome results
None listed