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

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ClinicalTrials.gov Identifier: NCT03622710
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sugalya Amatachaya, Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Rehabilitation Other: Rehabilitation therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Name: Walking training

Active Comparator: overground
Subjects are trained to walk overground for 5 days over 4 weeks.
Other: 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.
Other Name: Walking training




Primary Outcome Measures :
  1. 10-meter walk test (10MWT) [ Time Frame: Change over 4 weeks ]
    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)


Secondary Outcome Measures :
  1. Timed up and go test (TUGT) [ Time Frame: Change over 4 weeks ]
    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.

  2. Five times sit-to-stand test (FTSST) [ Time Frame: Change over 4 weeks ]
    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.

  3. 6-minute walk test (6MWT) [ Time Frame: Change over 4 weeks ]
    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

  4. Incidence of fall [ Time Frame: Six months after completing the training program. ]
    Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622710


Contacts
Contact: Donlaya Promkeaw +66-83-4177516 mai_en@windowslive.com

Locations
Thailand
Srinagarind hospital Recruiting
Khon Kaen, Thailand, 40000
Contact    834177516      
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Sugalya Amatachaya School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University

Responsible Party: Sugalya Amatachaya, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03622710     History of Changes
Other Study ID Numbers: PHD57I0062
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sugalya Amatachaya, Khon Kaen University:
Rehabilitation
Surfaces
Walking
Spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System