Immediate Effects of Stepping Training Using External Feedback in Spinal Cord Injury Patients

December 6, 2019 updated by: Sugalya Amatachaya, Khon Kaen University

Immediate Effects of Stepping Training With or Without External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury

  • Does stepping training with or without external feedback change functional ability of ambulatory patients with iSCI immediately after training?
  • Are there significant differences between the immediate effects of stepping training with or without external feedback in ambulatory patients with iSCI?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare immediate effects of stepping training with or without the utility of external feedback on functional ability relating to walking in ambulatory patients with iSCI (between-group comparison).

Secondary objective To compare immediate effects in a group of stepping training with or without the utility of external feedback on functional ability relating to walking in ambulatory patients with iSCI (within-group comparison).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Muang
      • Khon Kaen, Muang, Thailand, 40002
        • Faculty of Associated Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Independent ambulatory patients with iSCI at a chronic stage (Post-injury time > 12 months)
  • Traumatic cause or non-progressive disease
  • Independent walking with or without assistive devices at least 17 meters (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
  • Age at least 18 years
  • Body mass index (BMI) between 18.5 - 29.9 kg/m2.

Exclusion Criteria:

  • Any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as

    • Brain function disorders
    • Visual deficits that cannot be corrected using glasses or contact lens
    • Musculoskeletal pain (with an intensity of pain more than 5 out of 10 on a numerical rating pain scale)
    • Deformity of the musculoskeletal system
    • Unable to follow a command of the tests
    • Unstable medical conditions
    • Color blindness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A to B
Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).
Other: Stepping training with feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Other Names:
  • Experimental program
Other: Stepping training without feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Other Names:
  • Control program
Other: B to A
Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).
Other: Stepping training with feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Other Names:
  • Experimental program
Other: Stepping training without feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Other Names:
  • Control program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of walking balance using Timed up and go test [TUGT]
Time Frame: Baseline and immediately after complete one section training program
The test was designed to measure mobility and dynamic balance control related to walking. Subjects will be instructed to stand up from a standard chair, walk at a fastest and safe speed for 3 meters, turn around a traffic cone, walk back and sit down on the chair with or without a walking device. Then the average time required for the 3 trials will be recorded.
Baseline and immediately after complete one section training program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of walking speed using 10 meter walk test (10MWT)
Time Frame: Baseline and immediately after complete one section training program

The test assessed the time required over the 4 m in the middle of the 10-m walkway at a comfortable and fastest speed with or without an assistive device. The time was converted to a walking speed using the formula:

velocity (m/s) = distance (m)/ time (second).
Baseline and immediately after complete one section training program
Change of lower limb muscle strength using Five times sit-to-stand [FTSST]
Time Frame: Baseline and immediately after complete one section training program
The test has used to quantify lower extremity motor strength. The time taken to complete 5 chair-rise cycles at a fastest and safe speed will be recorded for each subject. Then the average time required for the 3 trials will be used for data analysis.
Baseline and immediately after complete one section training program
Change of lower limb support ability [LLSA] on more and less affected legs
Time Frame: Baseline and immediately after complete one section training program
The test was assessed to reflect a risk of musculoskeletal disorders. Participants stood upright with placing the tested leg on the digital load cell (Model L6E3-C, accuracy up to 0.1 kg, and uncertainty of the measurement ± 0.082 kg: patent application number 1701004050) and the other leg posterolaterally to the tested leg. Participants were instructed to shift their body-weight anterolaterally onto the tested leg as much as they could, and step the other leg forward, with or without using the arms according to their ability. Then the LLSA data was reported in term of percent of the participant's body-weight. These data were presented for the less and more affected limbs as identified using the sensorimotor scores. Each participant performed five trials per leg, the first two trials served as practice trials, and an other three trials were used for data analysis.
Baseline and immediately after complete one section training program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Sugalya Amatachaya, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2017

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHD57K0194

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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