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

Primary Purpose

Spinal Cord Injuries

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Stepping training without feedback

Stepping training with feedback

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Rehabilitation, Neurological condition, Walking ability, Feedback, External information

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Associated Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

A to B

B to A

Arm Description

Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).

Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).

Outcomes

Primary Outcome Measures

Change of walking balance using Timed up and go test [TUGT]

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.

Secondary Outcome Measures

Change of walking speed using 10 meter walk test (10MWT)

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).

Change of lower limb muscle strength using Five times sit-to-stand [FTSST]

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.

Change of lower limb support ability [LLSA] on more and less affected legs

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.

Full Information

NCT ID

NCT03875066

First Posted

March 10, 2019

Last Updated

December 6, 2019

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT03875066

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 19, 2017 (Actual)

Primary Completion Date

October 31, 2018 (Actual)

Study Completion Date

July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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?

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

Rehabilitation, Neurological condition, Walking ability, Feedback, External information

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A to B

Arm Type

Other

Arm Description

Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).

Arm Title

B to A

Arm Type

Other

Arm Description

Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).

Intervention Type

Other

Intervention Name(s)

Stepping training without feedback

Other Intervention Name(s)

Control program

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Stepping training with feedback

Other Intervention Name(s)

Experimental program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of walking balance using Timed up and go test [TUGT]

Description

Time Frame

Baseline and immediately after complete one section training program

Secondary Outcome Measure Information:

Title

Change of walking speed using 10 meter walk test (10MWT)

Description

Time Frame

Baseline and immediately after complete one section training program

Title

Change of lower limb muscle strength using Five times sit-to-stand [FTSST]

Description

Time Frame

Baseline and immediately after complete one section training program

Title

Change of lower limb support ability [LLSA] on more and less affected legs

Description

Time Frame

Baseline and immediately after complete one section training program

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sugalya Amatachaya

Organizational Affiliation

Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Associated Medical Science

City

Khon Kaen

State/Province

Muang

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

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

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