Stepping Training Using External Feedback in Spinal Cord Injury Patients

Spinal Cord Injuries Clinical Trial

Official title:

Effects of Stepping Training With External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254797
• Other study ID #: PHD/0194/2557
• Status: Completed
• Phase: N/A
• Start date: August 20, 2017
• Est. completion date: March 20, 2020

Study information

• Verified date: June 2020
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 20, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Stepping training with feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
• Stepping training without feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.

Locations

Country	Name	City	State
Thailand	Faculty of Associated Medical Science	Khon Kaen	Muang

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (23)

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Brotherton SS, Krause JS, Nietert PJ. Falls in individuals with incomplete spinal cord injury. Spinal Cord. 2007 Jan;45(1):37-40. Epub 2006 Feb 21. — View Citation

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Jackson AB, Carnel CT, Ditunno JF, Read MS, Boninger ML, Schmeler MR, Williams SR, Donovan WH; Gait and Ambulation Subcommittee. Outcome measures for gait and ambulation in the spinal cord injury population. J Spinal Cord Med. 2008;31(5):487-99. Review. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of walking stability using Timed up and go test [TUGT]	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.	prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Secondary	Change of walking speed using 10 meter walk test (10MWT)	The test measures walking speed. Subjects will be instructed to walk at a prefer speed and fastest speed along a 10 meters walkway with or without walking device. The video recording will be captured over the 4 meters in the middle walkway in order to minimize acceleration and deceleration effects. Then the data will be converted to a walking speed using a formula; (v = s/t)	prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Secondary	Change of lower limb muscle strength using Five times sit-to-stand [FTSST]	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.	prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
Secondary	Change of walking endurance using 6 minute walk test (6MWT)	The test measures the longest walking distance in 6 minute to reflect the responses of the cardiopulmonary and muscular systems. Subjects will be instructed to walk along a rectangular walkway as long as they can with a safety speed. They can walk with or without walking device in 6 minutes and are able to take a resting period as needed and continuing to walk. The distance covered after 6 minutes will be recorded.	prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program