Spina BifidaNCT05719636
Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
A study testing Conventional treatment and Progressive resistance exercise in people with Spina Bifida, run by Riphah International University at 1 site in Pakistan.
Trial summary
In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Conventional treatment and Progressive resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2022to 20 Apr 2023
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 16 year.
- Male and female both are included.
- Lower extremity weakness (less than 2).
- Knee and hip flexion contractures
Who cannot join
- Bowel and bladder dysfunction.
- Children having absent tone.
- Children having bone fracture
Trial locations and contacts
1 site in 1 country.
About this study
In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.
- Conditions
- Spina Bifida
- Being tested
- Conventional treatment, Progressive resistance exercise
- Keywords
- resistance exercise, endurance, functional mobility
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentOther
Conventional protocol that involves simple active and passive range of motion exercises of lower limb with positioning for assistive devices was provided
Progressive resistance exerciseOther
The protocol that was applied on the members of (experimental group) are progressive resistance exercises. These passive resistance exercises included Flexion, Extension, Abduction, Adduction of hip; Flexion, Extension of knee; with minimum time in start and minimum quantity of loads, with Thera bands and sandbags,.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Not described Receives: Other: Conventional treatment |
| Progressive resistance exercise | Experimental | Not described Receives: Other: Progressive resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Specific Functional Scale for lower extremity functional status
Patient Specific Functional Scale (PSFS) was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive and efficient outcome measure that would be easy to use and applicable to a large number of clinical presentations. Gives the patient positive re-enforcement that the intervention is effective. Can be used on a wide variety of musculoskeletal and neurological conditions
Measured: 6th week
Secondary outcomes (2)
6 minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 6th week
sit to stand test
The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand. While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start13 May 2022
- Primary completion15 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719636
- Sponsor's protocol ID
- REC/RCR & AHS/22/0740
- Status last verified
- Dec 2023
- First submitted
- 31 Jan 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
- ClinicalTrials.gov ID
- NCT05719636
- Acronym / sponsor ID
- REC/RCR & AHS/22/0740
- Conditions
- Spina Bifida
- Keywords
- resistance exercise, endurance, functional mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 9 Feb 2023 (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.
In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Other: Conventional treatment |
| Progressive resistance exercise | Experimental | Other: Progressive resistance exercise |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8 to 16 year.
- Male and female both are included.
- Lower extremity weakness (less than 2).
- Knee and hip flexion contractures
Key exclusion criteria (3 listed)
- Bowel and bladder dysfunction.
- Children having absent tone.
- Children having bone fracture
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 |
|---|---|---|
| Conventional treatmentConventional protocol that involves simple active and passive range of motion exercises of lower limb with positioning for assistive devices was provided | Other | Conventional treatment |
| Progressive resistance exerciseThe protocol that was applied on the members of (experimental group) are progressive resistance exercises. These passive resistance exercises included Flexion, Extension, Abduction, Adduction of hip; Flexion, Extension of knee; with minimum time in start and minimum quantity of loads, with Thera bands and sandbags,. | Other | Progressive resistance exercise |
Primary outcome
Patient Specific Functional Scale for lower extremity functional status
Time frame: 6th week
Patient Specific Functional Scale (PSFS) was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive and efficient outcome measure that would be easy to use and applicable to a large number of clinical presentations. Gives the patient positive re-enforcement that the intervention is effective. Can be used on a wide variety of musculoskeletal and neurological conditions
2 secondary outcomes
6 minute walk test
Time frame: 6th week
sit to stand test
Time frame: 6th Week
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 27 Dec 2023.
- Individual participant dataSharing planned: No
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EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
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Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
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Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida
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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.
Fareeha Kausar, MS principal investigator
Riphah International 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 Conventional treatment and Progressive resistance exercise in people with Spina Bifida, run by Riphah International University at 1 site in Pakistan.
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 4 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 27 Dec 2023. 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 Pakistan. 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?
Patient Specific Functional Scale for lower extremity functional status (time frame: 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2023.