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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622710
• Other study ID #: PHD57I0062
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: January 16, 2019

Study information

• Verified date: August 2019
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 16, 2019
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Rehabilitation
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Thailand	Srinagarind hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change over 4 weeks
Secondary	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.	Change over 4 weeks
Secondary	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.	Change over 4 weeks
Secondary	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	Change over 4 weeks
Secondary	Incidence of fall	Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone.	Six months after completing the training program.