Spinal Cord InjuriesNCT03622710
Effects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury
A study testing Rehabilitation therapy in people with Spinal Cord Injuries and Rehabilitation, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Rehabilitation
- What is being tested?
- Rehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2017to 16 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spinal Cord Injuries, Rehabilitation
- Being tested
- Rehabilitation therapy
- Keywords
- Rehabilitation, Surfaces, Walking, Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation therapyOther
Also called Walking training
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.
| Study group | Role | What they receive |
|---|---|---|
| Different surfaces | Experimental | Subjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks. Receives: Other: Rehabilitation therapy |
| overground | Active comparator | Subjects are trained to walk overground for 5 days over 4 weeks. Receives: Other: Rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change over 4 weeks
Secondary outcomes (4)
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.
Measured: Change over 4 weeks
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.
Measured: Change over 4 weeks
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
Measured: Change over 4 weeks
Incidence of fall
Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone.
Measured: Six months after completing the training program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jul 2017
- Primary completion15 Jul 2018
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sugalya Amatachaya, Khon Kaen University
- Investigators
- Sugalya Amatachaya, Principal investigator, School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622710
- Sponsor's protocol ID
- PHD57I0062
- Status last verified
- Aug 2019
- First submitted
- 10 Jan 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32926851
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03622710
- Acronym / sponsor ID
- PHD57I0062
- Conditions
- Spinal Cord Injuries, Rehabilitation
- Keywords
- Rehabilitation, Surfaces, Walking, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Different surfaces | Experimental | Other: Rehabilitation therapySubjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks. |
| overground | Active comparator | Other: Rehabilitation therapySubjects are trained to walk overground for 5 days over 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation therapyAlso: Walking trainingSubjects 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 | Different surfaces, overground |
Primary outcome
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)
4 secondary outcomes
Timed up and go test (TUGT)
Time frame: Change over 4 weeks
Five times sit-to-stand test (FTSST)
Time frame: Change over 4 weeks
6-minute walk test (6MWT)
Time frame: Change over 4 weeks
Incidence of fall
Time frame: Six months after completing the training program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 32926851Amatachaya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sugalya Amatachaya principal investigator
School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University Affiliation: Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation therapy in people with Spinal Cord Injuries and Rehabilitation, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-meter walk test (10MWT) (time frame: Change over 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.