NCT02917590

Brief Summary

Is dual-task obstacle crossing training more efficiently than single-task obstacle crossing training on the improvement of walking ability, balance ability, and lower extremity muscle strength in ambulatory subjects with spinal cord injury

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Status
unknown

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

October 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

September 22, 2016

Last Update Submit

September 26, 2016

Conditions

Keywords

Spinal cord injurydual-task obstacle crossing

Outcome Measures

Primary Outcomes (1)

  • 10MWT (Single-task)

    Walking speed in single-task condition

    1 day

Secondary Outcomes (3)

  • 10MWT (Dual-task)

    1 day

  • TUGT

    1 day

  • FTSST

    1 day

Study Arms (2)

Dual-task obstacle crossing training

EXPERIMENTAL

The four obstacles in the sizes of 4cm wide, 8cm wide, 4cm high, and 8cm high are randomly placed along a 10-meter walkway in 2-meter intervals. Subjects are instructed to walk continuously over obstacles at their comfortable speed, as good as they can without contact the obstacles by their leg or device. During walk over obstacles, subjects asked to perform simultaneously with a color word stroop task which requires subjects to see and answer the color of the name of a color words in the monitor (ignore the meaning) as quickly as possible, and loudly.

Other: Dual-task obstacle crossing training

Single-task obstacle crossing training

SHAM COMPARATOR

The four obstacles in the sizes of 4cm wide, 8cm wide, 4cm high, and 8cm high are randomly placed along a 10-meter walkway in 2-meter intervals. Subjects are asked to walk continuously over obstacles at their comfortable speed, as good as they can without contact the obstacles by their leg or device.

Other: Single-task obstacle crossing training

Interventions

Obstacle crossing simultaneously a color word stroop task training

Dual-task obstacle crossing training

Obstacle crossing training

Single-task obstacle crossing training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • independent ambulatory subjects with
  • traumatic causes or non-progressive diseases
  • sub-acute and chronic stage of injury (at least 3 month after injury)
  • body mass index (BMI) between 18.5-29.9 kg/m2
  • walk independently for at least 17 meters with or without assistive devices (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
  • able to read Thai

You may not qualify if:

  • pain in the musculoskeletal system with a pain scale more than 5 out of 10 on a the visual analog scale (VAS)
  • deformity in the joints that affect ambulatory ability
  • unable to understand the commands and tests used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sugalya Amatachaya, PhD

    School of Physical Therapy, 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

September 22, 2016

First Posted

September 28, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

September 28, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share