Clinical trial NCT03622710: Effects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury
Official title: Effects of Walking Training on Different Surfaces on Walking Ability, Balance Control, Lower Limb Muscle Strength, and Falls in Ambulatory Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Rehabilitation
Keywords: Rehabilitation
Surfaces
Walking
Spinal cord injury
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

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).

Primary outcomes:
measure: 10-meter walk test (10MWT)
timeFrame: Change over 4 weeks
Secondary outcomes:
measure: Timed up and go test (TUGT)
timeFrame: Change over 4 weeks
measure: Five times sit-to-stand test (FTSST)
timeFrame: Change over 4 weeks
measure: 6-minute walk test (6MWT)
timeFrame: Change over 4 weeks
measure: Incidence of fall
timeFrame: Six months after completing the training program.
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind hospital
Study officials:
affiliation: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University
name: Sugalya Amatachaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.