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

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Stroke

Treatments: Device: with auxiliary illuminator

Study type: Interventional

Funder types: Other

Identifiers

NCT03786341

VGHKS17-CT8-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

with auxiliary illuminator

Experimental group

Description:

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

Treatment:

Device: with auxiliary illuminator

control group

Placebo Comparator group

Description:

Ambulation training WITHOUT laser quad-cane.

Treatment:

Device: with auxiliary illuminator