Clinical trial NCT03875066: Immediate Effects of Stepping Training Using External Feedback in Spinal Cord Injury Patients
Official title: Immediate Effects of Stepping Training With or Without External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Rehabilitation
Neurological condition
Walking ability
Feedback
External information
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of walking balance using Timed up and go test [TUGT]
timeFrame: Baseline and immediately after complete one section training program
Secondary outcomes:
measure: Change of walking speed using 10 meter walk test (10MWT)
timeFrame: Baseline and immediately after complete one section training program
measure: Change of lower limb muscle strength using Five times sit-to-stand [FTSST]
timeFrame: Baseline and immediately after complete one section training program
measure: Change of lower limb support ability [LLSA] on more and less affected legs
timeFrame: Baseline and immediately after complete one section training program
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Associated Medical Science
state: Muang
Study officials:
affiliation: Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
name: Sugalya Amatachaya
role: PRINCIPAL_INVESTIGATOR
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