Clinical trial NCT03150979: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Assistive devices
Gait
Rehabilitation
Clinical trial
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-blinded, randomized, clinical trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Walking speed
timeFrame: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Secondary outcomes:
measure: Walking step length
timeFrame: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
measure: Walking cadence
timeFrame: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
measure: Walking capacity
timeFrame: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
measure: Walking confidence
timeFrame: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
measure: Social Participation
timeFrame: Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Department of Physical Therapy, Universidade Federal de Minas Gerais
state: MG
city: Belo Horizonte
country: Brazil
facility: NeuroGroup Laboratory
state: MG
Study officials:
affiliation: Federal University of Minas Gerais
name: Luci F Teixeira-Salmela, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: