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CompletedNCT03622710Updated Aug 28, 2019

Effects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury

An interventional study of Rehabilitation therapy in Spinal Cord Injuries and Rehabilitation, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The study compares effects of 4-week walking training program on a walking track with difference surface [WTDS] and a firm ground on functional ability of ambulatory individuals with incomplete spinal cord injury [iSCI], using within- and between-group comparisons.

02

Conditions studied

  • Spinal Cord Injuries
  • Rehabilitation

Keywords

  • Rehabilitation
  • Surfaces
  • Walking
  • Spinal cord injury
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In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 72 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age at least 18 years
  2. Having an incomplete SCI (the American Spinal Cord Injury Association (ASIA) Impairment Scale or AIS C or D) (Kirshblum et al., 2011)
  3. At a sub-acute or chronic stage of injury (post injury time: PIT > 3 months) (Wirth et al., 2008; Blackwell et al., 2001)
  4. Able to walk with or without a walking device for at least 10m (Behrman et al., 2005; Lam et al., 2008; Jackson et al., 2008)
  5. Having a body mass index (BMI) between 18.5-29.9 kg/m2 (Woo et al., 2007)

Exclusion criteria

Exclusion Criteria:

  1. Having an SCI from a progressive disease such as multiple sclerosis or malignancy
  2. Having other medical conditions that might affect ambulatory ability, such as pain in the musculoskeletal system with an intensity of pain more than 5 out of 10 on a numeric rating pain scale (Dijkers, 2010), deformities of the spine and lower extremities (i.e. scoliosis, kyphosis, and equinovarus) and other neurological or other medical disorders (thromboembolism, autonomic dysreflexia).
  3. Severe spasticity of the lower extremities (Modified Ashworth Scale (MAS) more than 2) (Bohannon \& Smith, 1987; Scivoletto et al., 2008).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Different surfaces

    Subjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks.

    Other: Rehabilitation therapy

  • Active comparator
    overground

    Subjects are trained to walk overground for 5 days over 4 weeks.

    Other: Rehabilitation therapy

Interventions

  • OtherRehabilitation therapy

    Subjects are trained to walk overground (control) or over WTDS (experimental) for 5 days/week over 4 week. Then they will be monthly follow-up for fall data.

    Also known as: Walking training

06

What researchers measure

Primary outcomes

  1. 10-meter walk test (10MWT)

    Subjects walk at a comfortable pace along a 10m walkway. The test records the time use over the middle 4m of the walkway in order to minimize acceleration and deceleration effects. Then the average time over the 3 trials is converted to walking speed using the formula v=distance (m) /time (s)

    Time frame: Change over 4 weeks

Secondary outcomes

  1. Timed up and go test (TUGT)

    Subjects stand up from a standard armchair, walk around a traffic cone that is located 3m away from the chair, and return to sit down on the chair at a maximum and safe speed. The test records the time taken from the command "Go" until the subject's back against the backrest of the chair. Then the average times finding over the 3 trials is used for data analysis.

    Time frame: Change over 4 weeks

  2. Five times sit-to-stand test (FTSST)

    The time taken to complete 5 chair-rise cycles at a fastest and safe speed is measured for each subject. Then the average time over the 3 trials is used for data analysis.

    Time frame: Change over 4 weeks

  3. 6-minute walk test (6MWT)

    Subjects walk along a rectangular walkway as long as possible in 6 minutes. Every minute during the test, they are informed the time left and encouraged to continue in a good manner. Subjects are able to take a period of rest as needed and continued walking as soon as they can. The distance covered after 6 minutes are recorded

    Time frame: Change over 4 weeks

  4. Incidence of fall

    Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone.

    Time frame: Six months after completing the training program.

07

Study locations

1 site
  • Srinagarind hospital
    Khon Kaen, 40000, Thailand
08

References and documents

Publications

  • Amatachaya S, Promkeaw D, Arayawichanon P, Thaweewannakij T, Amatachaya P. Various Surfaces Benefited Functional Outcomes and Fall Incidence in Individuals With Spinal Cord Injury: A Randomized Controlled Trial With Prospective Data Follow-up. Arch Phys Med Rehabil. 2021 Jan;102(1):19-26. doi: 10.1016/j.apmr.2020.08.009. Epub 2020 Sep 11. PubMed 32926851 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03622710
Lead sponsor
Khon Kaen University
Responsible party
Sugalya Amatachaya (School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen University) — Principal investigator
First posted
Aug 9, 2018
Start date
Jul 1, 2017
Primary completion
Jul 15, 2018
Completion
Jan 16, 2019
Last update
Aug 28, 2019

Study contacts

Sugalya Amatachaya
principal investigator · School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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