NCT03702517

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

October 4, 2018

Last Update Submit

January 10, 2024

Conditions

Chronic Stroke Patients

Keywords

lateral stair walkingrange of motionmuscle strength

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • The postural assessment scale for stroke patients (PASS)

    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,

    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)

    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)

    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.

    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.

  • +3 more secondary outcomes

Study Arms (2)

lateral stair walking exercise

EXPERIMENTAL

The experimental group received 15 minutes of lateral stair walking exercise

Device: lateral stair walking exerciseDevice: traditional physiotherapy

traditional physiotherapy

ACTIVE COMPARATOR

strengthening exercise, balance training and gait training

Device: lateral stair walking exerciseDevice: traditional physiotherapy

Interventions

lateral stair walking exerciseDEVICE

15 minutes of lateral stair walking exercise

Also known as: stair walking training
lateral stair walking exercisetraditional physiotherapy
traditional physiotherapyDEVICE

strengthening exercise, balance training and gait training

Also known as: physical therapy
lateral stair walking exercisetraditional physiotherapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • I-Hsiu Liou, MD.

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, Principal Investigator, Assistant Professor)

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 11, 2018

Study Start

January 3, 2016

Primary Completion

May 5, 2016

Study Completion

December 30, 2016

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share