Lateral Stair Walking Training After Chronic Stroke

Efficacy of Lateral Stair Walking Training in Patients With Chronic Stroke: a Pilot Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke Patients
• Intervention / Treatment: Device: lateral stair walking exercise; Device: traditional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lateral stair walking exercise; The experimental group received 15 minutes of lateral stair walking exercise	Device: lateral stair walking exercise; 15 minutes of lateral stair walking exercise; Other Names: stair walking training; Device: traditional physiotherapy; strengthening exercise, balance training and gait training; Other Names: physical therapy
Active Comparator: traditional physiotherapy; strengthening exercise, balance training and gait training	Device: lateral stair walking exercise; 15 minutes of lateral stair walking exercise; Other Names: stair walking training; Device: traditional physiotherapy; strengthening exercise, balance training and gait training; Other Names: physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	Mycroft 3 hand-held dynamometer18: It has good reliability. Muscle strength can be measured in Newton's. It is applied in assessing the muscle strength of subjects.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postural assessment scale for stroke patients (PASS)	The PASS assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance. Its advantage lies in the lack of ceiling effect and floor effect, and the static and dynamic balance of stroke patients can be assessed. It is rated on a scale from 0 to 3, (total score of = 36) The Higher scores indicate better balance in stroke patients.	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.
Fugal-Meyer assessment for Lower extremity,	It is an assessment scale developed from Brunnstrom stage-L/E specifically dedicated to stroke patients. It is rated on a scale from 0 to 2. It has good reliability and validity.	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.
Barthel index for Activities of Daily Living (ADL)	It is a basic scale for functional independence with reliability and validity, covering 10 items such as eating, transposition, personal hygiene, using the bathroom, showering, walking on flat ground, stair climbing, putting on clothes, controlling excretion, etc. The total score ranges from 0 to 100, which is the progressive scope for activities of daily living .	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.
Timed up and go test (TUG)	In the Timed Up and Go Test time is recorded when rising from a chair, walking three metres, turning, and walking back. It has good sensitivity and specificity (sensitivity=87%, specificity=87%), and can assess balance and motor ability. The measured time can predict the fall of stroke patients.	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.
Reha Gait® for gait parameters.	It has high reliability. By wearing the three-axis gyro sensor on the shoes, gait data can be collected and analyzed with a microcomputer via Bluetooth.	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.
Passive range of motion (PROM)	Passive range of motion (PROM) and active range of motion (AROM) of hip, knee and ankle joints: The change in degree is measured with a goniometer before and after training.	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.
active range of motion (AROM)	Passive range of motion (PROM) and active range of motion (AROM) of hip, knee and ankle joints: The change in degree is measured with a goniometer before and after training.	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.
The Brunnstrom motor recovery stage of Lower extremity (LE):	The motor recovery was assessed using Brunnstrom motor recovery stage tool (Brunnstrom, 1970) that classifies it into 6 stages; 1) flaccidity; 2) spasticity is developing; 3) spasticity is maximum; 4) spasticity begins to decrease and some movement combinations become available; 5) spasticity is diminishing and more difficult movement combinations can be accomplish; 6) normal. It has good reliability and validity, and can assess the motor recovery of stroke patients. It is rated on a scale from 1 to 6.	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.

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Investigators: Study Chair: I-Hsiu Liou, MD., Kaohsiung Veterans General Hospital.

Publications and helpful links

Helpful Links

• Kaohsiung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2016
• Primary Completion (Actual): May 5, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: muscle strength; range of motion; lateral stair walking
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: VGHKS15-CT8-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No