NCT02916797

Brief Summary

  • Are there differences in immediate effects of stepping training with and without the use of visually weight-taking machine (VWTM) on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?
  • Are there differences of 4-week stepping training with and without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

March 12, 2019

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

September 22, 2016

Last Update Submit

March 8, 2019

Conditions

Keywords

FeedbackPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • 10MWT

    Walking speed

    4 weeks

Secondary Outcomes (3)

  • 6MWT

    4 weeks

  • TUGT

    4 weeks

  • Lower limb support ability

    4 weeks

Study Arms (2)

Stepping training with feedback

EXPERIMENTAL

Subjects stand in a step standing position with placing the affected leg on the load cells of the VWTM and the non-affected leg slightly backward outside the load cells, look forward to light bars of the displayed section which will be set at their eye level. Then subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can. Subjects repetitively practice the task for 30 minutes with a period of sufficient rest as required.

Other: Stepping training with feedback

Stepping training without feedback

NO INTERVENTION

Subjects will be trained and instructed the same as the experimental group but without using the displayed section, for approximately 30 minutes/day (excluding rest periods), 5 days/week, for 4 week. Then, every subject will be trained to walk overground with or without a walking device for 10 minutes in order to promote transferability of the part-task practice to the whole/target task. Subjects still receive routine treatments from other rehabilitation professionals as needed during participation in the study.

Interventions

Stepping training with the use of external feedback. The subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can.

Stepping training with feedback

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are independent ambulatory patients with first stroke episode with the age at least 45-74 years old,
  • subacute (post-stroke time \< 6 months) or chronic (post-stroke time ≥ 6 months) stroke
  • Independent walking at least 10 meters with or without a walking device
  • Able to follow verbal command used in this study

You may not qualify if:

  • The subjects who have other medical conditions that might affect participation in the study such as uncontrolled underlying diseases (i.e. hypertension, heart disease, thyroid, etc.), deformity in the lower extremities, pain more than 5 out of 10 on a visual analog scale, legally blind or had a history of visual deficits that were unable to be corrected by glasses or contact lens, have a color blindness and inability to communicate or follow the commands used in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sugalya Amatachay, Ph.D.

    School of Physical Therapy,Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 27, 2016

Study Start

April 10, 2016

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

March 12, 2019

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share