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

NCT ID: NCT03622710

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Different surfaces

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

Group Type EXPERIMENTAL

Rehabilitation therapy

Intervention Type OTHER

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.

overground

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

Group Type ACTIVE_COMPARATOR

Rehabilitation therapy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rehabilitation 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Walking training

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sugalya Amatachaya

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sugalya Amatachaya

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Srinagarind hospital

Khon Kaen, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32926851 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHD57I0062

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.