Efficacy of a Novel Walking Assist Device With Auxiliary Laser Illuminator on Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-12-05

Brief Summary

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Many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs.

Ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke.

Walking assist device with auxiliary laser illuminator during ambulation training could correct gait parameters, improve balance and basic activity of daily living among stroke patients.

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Detailed Description

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Facilitation of normal gait is a primary goal of rehabilitation on patients with stroke. The investigators aimed to investigate whether walking assist device with auxiliary lser illuminator (laser quad-cane) providing visual feedback during ambulation could improve parameters of gait cycle and function among patients with chronic stroke.

Methods: This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patients who fulfilled the inclusion and exclusion criteria were randomized (1:1) into two groups, using sequentially numbered, opaque, sealed envelopes (SNOSE) method containing a group assignment number by a person who was not clinically involved in and, therefore, was blinded to this study.

Study Groups

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with auxiliary illuminator

the walking training was by conventional strategy with lase quad-cane.

Group Type EXPERIMENTAL

with auxiliary illuminator

Intervention Type DEVICE

Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.

control group

Ambulation training WITHOUT laser quad-cane.

Group Type PLACEBO_COMPARATOR

with auxiliary illuminator

Intervention Type DEVICE

Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.

Interventions

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with auxiliary illuminator

Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.

Intervention Type DEVICE

Other Intervention Names

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control group

Eligibility Criteria

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Inclusion Criteria

* Stroke patients at subacute (stroke symptoms between three months to one year) or chronic stage (stroke symptoms more than 1 year)
* with hemiplegia
* with sufficient cognition that could follow the instructions and procedure
* walk independently for a distance of more than 20 meters with or without the use of a walking aid.

Exclusion Criteria

* Stroke patients with other neurological diseases like Parkinsonism,
* Myopathy
* Multiple sclerosis
* Spinal cord injury that might interfere with walking ability

Eligible Sex

ALL

Accepts Healthy Volunteers

No