Immediate Effects of Stepping Training Using External Feedback in Spinal Cord Injury Patients

NCT03875066 | Completed DMC

• 1 other identifier: PHD57K0194
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Spinal Cord Injuries

Keywords

Rehabilitation; Neurological condition; Walking ability; Feedback; External information

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of walking speed using 10 meter walk test (10MWT)

  Baseline and immediately after complete one section training program

• Change of lower limb muscle strength using Five times sit-to-stand [FTSST]

  Baseline and immediately after complete one section training program

• Change of lower limb support ability [LLSA] on more and less affected legs

  Baseline and immediately after complete one section training program

Study Arms (2)

A to B

OTHER

Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).

Other: Stepping training without feedback; Other: Stepping training with feedback

B to A

OTHER

Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).

Other: Stepping training without feedback; Other: Stepping training with feedback

Interventions

Stepping training without feedback OTHER

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.

Also known as: Control program

A to B; B to A

Stepping training with feedback OTHER

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.

Also known as: Experimental program

A to B; B to A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Associated Medical Science

Khon Kaen, Muang, 40002, Thailand

Location

Related 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.

  PMID: 19208261 BACKGROUND

• 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.

  PMID: 24090447 BACKGROUND

• 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.

  PMID: 19139759 BACKGROUND

• 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.

  PMID: 24445972 BACKGROUND

• 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.

  PMID: 21151192 BACKGROUND

• Baer G, Smith M. The recovery of walking ability and subclassification of stroke. Physiother Res Int. 2001;6(3):135-44. doi: 10.1002/pri.222.

  PMID: 11725595 BACKGROUND

• 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. doi: 10.1016/j.apmr.2006.10.004.

  PMID: 17207674 BACKGROUND

• 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. doi: 10.2522/ptj.20050212.

  PMID: 17012645 BACKGROUND

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

  PMID: 10869131 BACKGROUND

• Bohannon RW. Manual muscle testing: does it meet the standards of an adequate screening test? Clin Rehabil. 2005 Sep;19(6):662-7. doi: 10.1191/0269215505cr873oa.

  PMID: 16180603 BACKGROUND

• 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. doi: 10.1016/s0003-9993(95)80509-5.

  PMID: 7763154 BACKGROUND

• 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. doi: 10.1080/10790268.2007.11753932.

  PMID: 17684890 BACKGROUND

• Brotherton SS, Krause JS, Nietert PJ. Falls in individuals with incomplete spinal cord injury. Spinal Cord. 2007 Jan;45(1):37-40. doi: 10.1038/sj.sc.3101909. Epub 2006 Feb 21.

  PMID: 16491105 BACKGROUND

• 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. doi: 10.1093/brain/117.5.1143.

  PMID: 7953595 BACKGROUND

• Capato TT, Tornai J, Avila 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.

  PMID: 26347052 BACKGROUND

• 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. doi: 10.1038/sc.1992.147.

  PMID: 1484726 BACKGROUND

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

  PMID: 8351906 BACKGROUND

• 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.

  PMID: 18462283 BACKGROUND

• 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. doi: 10.1080/10790268.2008.11753644.

  PMID: 19086706 BACKGROUND

• 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. doi: 10.1038/sj.sc.3101167.

  PMID: 11438855 BACKGROUND

• 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. doi: 10.1093/gerona/57.8.m539.

  PMID: 12145369 BACKGROUND

• 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(Pt 2):389-404. doi: 10.1111/j.1469-7793.2000.00389.x.

  PMID: 11034628 BACKGROUND

• 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. doi: 10.1016/j.apmr.2006.05.024.

  PMID: 16935058 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sugalya Amatachaya

  Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 14, 2019
• Study Start: April 19, 2017
• Primary Completion: October 31, 2018
• Study Completion: July 31, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)