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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03875066
Other study ID # PHD57K0194
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2017
Est. completion date July 31, 2019

Study information

Verified date March 2019
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 31, 2019
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

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)

Ada L, Dean CM, Lindley R, Lloyd G. Improving community ambulation after stroke: the AMBULATE Trial. BMC Neurol. 2009 Feb 11;9:8. doi: 10.1186/1471-2377-9-8. — View Citation

Amatachaya S, Amatachaya P, Keawsutthi M, Siritaratiwat W. External cues benefit walking ability of ambulatory patients with spinal cord injury. J Spinal Cord Med. 2013 Nov;36(6):638-44. doi: 10.1179/2045772312Y.0000000086. Epub 2013 Apr 12. — View Citation

Amatachaya S, Keawsutthi M, Amatachaya P, Manimmanakorn N. Effects of external cues on gait performance in independent ambulatory incomplete spinal cord injury patients. Spinal Cord. 2009 Sep;47(9):668-73. doi: 10.1038/sc.2008.168. Epub 2009 Jan 13. — View Citation

Amatachaya S, Naewla S, Srisim K, Arrayawichanon P, Siritaratiwat W. Concurrent validity of the 10-meter walk test as compared with the 6-minute walk test in patients with spinal cord injury at various levels of ability. Spinal Cord. 2014 Apr;52(4):333-6. doi: 10.1038/sc.2013.171. Epub 2014 Jan 21. — View Citation

Amatachaya S, Wannapakhe J, Arrayawichanon P, Siritarathiwat W, Wattanapun P. Functional abilities, incidences of complications and falls of patients with spinal cord injury 6 months after discharge. Spinal Cord. 2011 Apr;49(4):520-4. doi: 10.1038/sc.2010.163. Epub 2010 Dec 14. — View Citation

Baer G, Smith M. The recovery of walking ability and subclassification of stroke. Physiother Res Int. 2001;6(3):135-44. — View Citation

Balasubramanian CK, Bowden MG, Neptune RR, Kautz SA. Relationship between step length asymmetry and walking performance in subjects with chronic hemiparesis. Arch Phys Med Rehabil. 2007 Jan;88(1):43-9. — View Citation

Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and training: an emerging paradigm shift in rehabilitation and walking recovery. Phys Ther. 2006 Oct;86(10):1406-25. Review. — View Citation

Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700. Review. — View Citation

Bohannon RW, Smith J, Hull D, Palmeri D, Barnhard R. Deficits in lower extremity muscle and gait performance among renal transplant candidates. Arch Phys Med Rehabil. 1995 Jun;76(6):547-51. — View Citation

Bohannon RW. Manual muscle testing: does it meet the standards of an adequate screening test? Clin Rehabil. 2005 Sep;19(6):662-7. — View Citation

Brotherton SS, Krause JS, Nietert PJ. A pilot study of factors associated with falls in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2007;30(3):243-50. — View Citation

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

Calancie B, Needham-Shropshire B, Jacobs P, Willer K, Zych G, Green BA. Involuntary stepping after chronic spinal cord injury. Evidence for a central rhythm generator for locomotion in man. Brain. 1994 Oct;117 ( Pt 5):1143-59. — View Citation

Capato TT, Tornai J, Ávila P, Barbosa ER, Piemonte ME. Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease. BMC Neurol. 2015 Sep 7;15:162. doi: 10.1186/s12883-015-0418-x. — View Citation

Crozier KS, Cheng LL, Graziani V, Zorn G, Herbison G, Ditunno JF Jr. Spinal cord injury: prognosis for ambulation based on quadriceps recovery. Paraplegia. 1992 Nov;30(11):762-7. — View Citation

Dobkin BH. Neuroplasticity. Key to recovery after central nervous system injury. West J Med. 1993 Jul;159(1):56-60. Review. — View Citation

Graham JE, Ostir GV, Fisher SR, Ottenbacher KJ. Assessing walking speed in clinical research: a systematic review. J Eval Clin Pract. 2008 Aug;14(4):552-62. doi: 10.1111/j.1365-2753.2007.00917.x. Epub 2008 May 2. Review. — View Citation

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

Lapointe R, Lajoie Y, Serresse O, Barbeau H. Functional community ambulation requirements in incomplete spinal cord injured subjects. Spinal Cord. 2001 Jun;39(6):327-35. — View Citation

Lord SR, Murray SM, Chapman K, Munro B, Tiedemann A. Sit-to-stand performance depends on sensation, speed, balance, and psychological status in addition to strength in older people. J Gerontol A Biol Sci Med Sci. 2002 Aug;57(8):M539-43. — View Citation

Pang MY, Yang JF. The initiation of the swing phase in human infant stepping: importance of hip position and leg loading. J Physiol. 2000 Oct 15;528 Pt 2:389-404. — View Citation

Wirz M, van Hedel HJ, Rupp R, Curt A, Dietz V. Muscle force and gait performance: relationships after spinal cord injury. Arch Phys Med Rehabil. 2006 Sep;87(9):1218-22. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Change of walking balance 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. Baseline and immediately after complete one section training program
Secondary Change of walking speed using 10 meter walk test (10MWT) The test assessed the time required over the 4 m in the middle of the 10-m walkway at a comfortable and fastest speed with or without an assistive device. The time was converted to a walking speed using the formula:
velocity (m/s) = distance (m)/ time (second).
Baseline and immediately after complete one section 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. Baseline and immediately after complete one section training program
Secondary Change of lower limb support ability [LLSA] on more and less affected legs The test was assessed to reflect a risk of musculoskeletal disorders. Participants stood upright with placing the tested leg on the digital load cell (Model L6E3-C, accuracy up to 0.1 kg, and uncertainty of the measurement ± 0.082 kg: patent application number 1701004050) and the other leg posterolaterally to the tested leg. Participants were instructed to shift their body-weight anterolaterally onto the tested leg as much as they could, and step the other leg forward, with or without using the arms according to their ability. Then the LLSA data was reported in term of percent of the participant's body-weight. These data were presented for the less and more affected limbs as identified using the sensorimotor scores. Each participant performed five trials per leg, the first two trials served as practice trials, and an other three trials were used for data analysis. Baseline and immediately after complete one section training program
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