NCT03622710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

January 10, 2018

Last Update Submit

August 24, 2019

Conditions

Spinal Cord InjuriesRehabilitation

Keywords

RehabilitationSurfacesWalkingSpinal cord injury

Outcome Measures

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)

    Change over 4 weeks

Secondary Outcomes (4)

  • Timed up and go test (TUGT)

    Change over 4 weeks

  • Five times sit-to-stand test (FTSST)

    Change over 4 weeks

  • 6-minute walk test (6MWT)

    Change over 4 weeks

  • Incidence of fall

    Six months after completing the training program.

Study Arms (2)

Different surfaces

EXPERIMENTAL

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

Other: Rehabilitation therapy

overground

ACTIVE COMPARATOR

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

Other: Rehabilitation therapy

Interventions

Rehabilitation therapyOTHER

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
Different surfacesoverground

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 18 years
  • Having an incomplete SCI (the American Spinal Cord Injury Association (ASIA) Impairment Scale or AIS C or D) (Kirshblum et al., 2011)
  • At a sub-acute or chronic stage of injury (post injury time: PIT \> 3 months) (Wirth et al., 2008; Blackwell et al., 2001)
  • 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)
  • Having a body mass index (BMI) between 18.5-29.9 kg/m2 (Woo et al., 2007)

You may not qualify if:

  • Having an SCI from a progressive disease such as multiple sclerosis or malignancy
  • 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).
  • Severe spasticity of the lower extremities (Modified Ashworth Scale (MAS) more than 2) (Bohannon \& Smith, 1987; Scivoletto et al., 2008).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind hospital

Khon Kaen, 40000, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 32926851DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sugalya Amatachaya

    School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University

Study Record Dates

First Submitted

January 10, 2018

First Posted

August 9, 2018

Study Start

July 1, 2017

Primary Completion

July 15, 2018

Study Completion

January 16, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)