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Completed

NCT Number: NCT03254797

Stepping Training Using External Feedback in Spinal Cord Injury Patients

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?

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Associated Medical Science

Khon Kaen, Muang, 40002, Thailand

About this study

To compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with iSCI (between-group comparison).

To compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Change of walking stability using Timed up and go test [TUGT]

    Time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the 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.

Secondary outcomes

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

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

    The test measures walking speed. Subjects will be instructed to walk at a prefer speed and fastest speed along a 10 meters walkway with or without walking device. The video recording will be captured over the 4 meters in the middle walkway in order to minimize acceleration and deceleration effects. Then the data will be converted to a walking speed using a formula; (v = s/t)

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

    Time frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the 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.

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

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

    The test measures the longest walking distance in 6 minute to reflect the responses of the cardiopulmonary and muscular systems. Subjects will be instructed to walk along a rectangular walkway as long as they can with a safety speed. They can walk with or without walking device in 6 minutes and are able to take a resting period as needed and continuing to walk. The distance covered after 6 minutes will be recorded.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Effects of Stepping Training With External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 21, 2017
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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