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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Stepping training without feedback; Other: Stepping training with feedback

• Registration Number: NCT03875066
• Lead Sponsor: Khon Kaen University

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).

Study Timeline

• Study Start: 2017-04-19
• Primary Completion: 2018-10-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Completion: 2019-07-31
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A to B	Stepping training without feedback	Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).
A to B	Stepping training with feedback	Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).
B to A	Stepping training without feedback	Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).
B to A	Stepping training with feedback	Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).

Primary Outcome Measures

Name	Time	Method
Change of walking balance using Timed up and go test [TUGT]	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 Outcome Measures

Name	Time	Method
Change of walking speed using 10 meter walk test (10MWT)	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).
Change of lower limb muscle strength using Five times sit-to-stand [FTSST]	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.
Change of lower limb support ability [LLSA] on more and less affected legs	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.

Trial Locations

Locations (1)

Faculty of Associated Medical Science; 🇹🇭 Khon Kaen, Muang, Thailand