Stepping Training Using External Feedback in Spinal Cord Injury Patients

NCT03254797 | Completed DMC

• 1 other identifier: PHD/0194/2557
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI? Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI?

Conditions

Spinal Cord Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of walking stability 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.

  prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Secondary Outcomes (3)

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

  prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

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

  prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

• Change of walking endurance using 6 minute walk test (6MWT)

  prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Study Arms (2)

Stepping training with feedback

EXPERIMENTAL

Subjects will be instructed to perform the stepping task with external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes. They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total.

Other: Stepping training with feedback

Stepping training without feedback

ACTIVE COMPARATOR

Subjects will be instructed to perform the stepping task without external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes. They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total.

Other: Stepping training without feedback

Interventions

Stepping training with feedback OTHER

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.

Stepping training with feedback

Stepping training without feedback OTHER

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.

Stepping training without feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Independent ambulatory patients with iSCI
• Non-traumatic or traumatic causes
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Associated Medical Science

Khon Kaen, Muang, 40002, Thailand

Location

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sugalya Amatachaya

  School of Physical Therapy, 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: August 15, 2017
• First Posted: August 21, 2017
• Study Start: August 20, 2017
• Primary Completion: September 20, 2019
• Study Completion: March 20, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)