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Completed

NCT Number: NCT03875066

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

* 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?

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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–70 year

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 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).

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 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

Treatment and study plan

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.

Other names: Control program

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.

Other names: Experimental program

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 14, 2019
Registry last updated
Dec 9, 2019

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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