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

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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