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

K

Khon Kaen University

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Other: Stepping training without feedback
Other: Stepping training with feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT03875066
PHD57K0194

Details and patient eligibility

About

  • 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?

Full 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).

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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