Clinical trial NCT03786341: Efficacy of a Novel Walking Assist Device With Auxiliary Laser Illuminator on Stroke Patients
Official title: Kaohsiung Veterans General Hospital , Kaohsiung, Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Gait
Stroke
Walking assist device
Auxiliary illuminator
visual feedback
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of stride length (meter) of parameters of gait cycle.
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change of cadence(step/min) of parameters of gait cycle
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change of duration of stance phase(%) of parameters of gait cycle
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change of duration of swing phase(%) of parameters of gait cycle
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change of duration of single support (%) of parameters of gait cycle
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change of double support (%)during the gait cycle
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change ofangle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle)
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: The change ofangle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle)
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
Secondary outcomes:
measure: The Berg balance scale (BBS)
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: Barthel index (BI)
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
measure: Timed up and go test (TUG)
timeFrame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.
Other outcomes:
Locations:
city: Kaohsiung,
country: Taiwan
facility: Kaohsiung Veterans General Hospital ,
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Pei-Te Hsu, MD.
role: STUDY_DIRECTOR
References: