Clinical trial NCT03254797: Stepping Training Using External Feedback in Spinal Cord Injury Patients
Official title: Effects of Stepping Training With 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: 2017-08-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of walking stability using Timed up and go test [TUGT]
timeFrame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Secondary outcomes:
measure: Change of walking speed using 10 meter walk test (10MWT)
timeFrame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
measure: Change of lower limb muscle strength using Five times sit-to-stand [FTSST]
timeFrame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
measure: Change of walking endurance using 6 minute walk test (6MWT)
timeFrame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Associated Medical Science
state: Muang
Study officials:
affiliation: School of Physical Therapy, Khon Kaen University, Thailand
name: Sugalya Amatachaya
role: PRINCIPAL_INVESTIGATOR
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