Stepping Training Using External Feedback in Spinal Cord Injury Patients

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

NCT03254797

PHD/0194/2557

Details and patient eligibility

About

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?

Full 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).

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Stepping training with feedback

Experimental group

Description:

Subjects will be instructed to perform the stepping task with external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes. They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total.

Treatment:

Other: Stepping training with feedback

Stepping training without feedback

Active Comparator group

Description:

Subjects will be instructed to perform the stepping task without external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes. They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total.

Treatment:

Other: Stepping training without feedback