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Completed

NCT Number: NCT03622710

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Rehabilitation Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Srinagarind hospital

Khon Kaen, 40000, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rehabilitation therapy

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.

Other names: Walking training

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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