Back to resultsEffects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Rehabilitation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Rehabilitation, Surfaces, Walking, Spinal cord injury
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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).
Sites / Locations
- Srinagarind hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Different surfaces
overground
Arm Description
Subjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks.
Subjects are trained to walk overground for 5 days over 4 weeks.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Timed up and go test (TUGT)
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.
Five times sit-to-stand test (FTSST)
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.
6-minute walk test (6MWT)
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
Incidence of fall
Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03622710
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
January 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Rehabilitation
Keywords
Rehabilitation, Surfaces, Walking, Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Different surfaces
Arm Type
Experimental
Arm Description
Subjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks.
Arm Title
overground
Arm Type
Active Comparator
Arm Description
Subjects are trained to walk overground for 5 days over 4 weeks.
Intervention Type
Other
Intervention Name(s)
Rehabilitation therapy
Other Intervention Name(s)
Walking training
Intervention Description
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.
Primary Outcome Measure Information:
Title
10-meter walk test (10MWT)
Description
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)
Time Frame
Change over 4 weeks
Secondary Outcome Measure Information:
Title
Timed up and go test (TUGT)
Description
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.
Time Frame
Change over 4 weeks
Title
Five times sit-to-stand test (FTSST)
Description
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.
Time Frame
Change over 4 weeks
Title
6-minute walk test (6MWT)
Description
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
Time Frame
Change over 4 weeks
Title
Incidence of fall
Description
Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone.
Time Frame
Six months after completing the training program.
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sugalya Amatachaya
Organizational Affiliation
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind hospital
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32926851
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.
Results Reference
derived
Learn more about this trial
Effects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury
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