Clinical trial NCT03702517: Lateral Stair Walking Training After Chronic Stroke
Official title: Efficacy of Lateral Stair Walking Training in Patients With Chronic Stroke: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke Patients
Keywords: lateral stair walking
range of motion
muscle strength
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The experimental group received 15 minutes of lateral stair walking exercise and 30 minutes of traditional physiotherapy (strengthening exercise, balance training and gait training) each time.

The measures were done by one experience physical therapist (not involve in the intervention) before receiving the intervention and at weeks four, eight, and twelve. It took 45 minutes for each subject to complete all measures each time.

Detailed description: For lateral stair walking training, the dynamic stair trainer features four steps. The height can be adjusted from 0 to 16.5 centimeters, the stair was 0.74 m in width, with each step being 16 cm deep and 10 cm long. The experimental group received different heights of lateral stair walking training according to the patients' ability. The patients went up the stairs with the affected leg up first and they went down stairs with the sound leg leading first. For safety, the subjects held a handrail during the lateral stair walking exercise. The control group received traditional physiotherapy (strengthening exercise, balance training and gait training) for 30 minutes. Both the experimental group and control group received the intervention once a week for 12 weeks. All the interventions were done by the same physical therapist.

Eligibility criteria: Inclusion Criteria:

* subjects who were diagnosed with stroke within 6 months to 6 years by a neurologist or physiatrists,
* computerized tomography scan or magnetic resonance imaging scan showed unilateral brain damage,
* no obvious cognitive impairment,
* no serious bone and joint problems
* could follow the instructions and steps of the experiment
* walked 15 meters independently.

Exclusion Criteria:

* cognitively impaired,
* visually impairedor
* unable to receive training due to other diseases (lung, heart, gastrointestinal tract, bone and muscle, nervous system etc.)

Primary outcomes:
measure: muscle strength
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
Secondary outcomes:
measure: The postural assessment scale for stroke patients (PASS)
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: Fugal-Meyer assessment for Lower extremity,
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: Barthel index for Activities of Daily Living (ADL)
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: Timed up and go test (TUG)
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: Reha Gait® for gait parameters.
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: Passive range of motion (PROM)
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: active range of motion (AROM)
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
measure: The Brunnstrom motor recovery stage of Lower extremity (LE):
timeFrame: Both the experimental group and control group received the intervention once a week for 12 weeks.The measures were done by one experience physical therapist before receiving the intervention and at weeks four, eight, and twelve.
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: I-Hsiu Liou, MD.
role: STUDY_CHAIR
References: