DiplegiaNCT04723641
Effect of Functional Training on Motor Performance
A study testing functional training exercises in people with Diplegia, run by Badr University at 1 site in Egypt.
Trial summary
The functional strength training is mainly dealt with anti-gravity muscles and aiming at maximal carry over in day to day activities. The functional strength training can be given using resistance and it may be gravity, body weight, resistance bands and free weights. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Diplegia
- What is being tested?
- functional training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 30 Apr 2021
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ranged from 7 to 10 years old.
- The degree of spasticity ranged from grade 1 to 2 hypertonia according to Modified Ashwarth Scale (MAS)
- Level II and III on GMFCS-ER
- They were able to understand and follow verbal instructions
Who cannot join
- 1- visual or auditory problems. 2- Orthopedic surgery in the lower limb in the last 12 months before the study. 3- Fixed deformities in joints and bones of lower limbs. 4- Botox injection in the last six months before the study. 5- Children with any special medications affecting muscle functions (anti-spastic drugs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Functional Strength Training From Plantigrade Foot Position on Motor Performance in Children With Diplegia
The functional strength training is mainly dealt with anti-gravity muscles and aiming at maximal carry over in day to day activities. The functional strength training can be given using resistance and it may be gravity, body weight, resistance bands and free weights. The exercises are specific to the muscle or muscle groups recruited during the functional activities
- Conditions
- Diplegia
- Being tested
- functional training exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional training exercisesOther
progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Experimental | they received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training. Receives: Other: functional training exercises |
| control group | No intervention | received a designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor functional measurement
The GMFM is a standardized observational scale designed and validated to measure change in gross motor function over time in children with CP.
Measured: pre and after 3 months of intervention,, the higer score will represent the improvement
Secondary outcomes (1)
Isometric muscle strength measurements
The gold standard for evaluating isometric muscle strength is the portable dynamometer. This is an easy-to-use, sensitive device for detecting muscular action and for performing objective, valid, and reliable measurements in several populations
Measured: pre and after 3 months of intervention,, increase in muscle will represent the improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start20 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiplegiaStudies 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
- Model description
- intervention group received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa mohsen, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723641
- Sponsor's protocol ID
- Hana 5
- Status last verified
- Apr 2023
- First submitted
- 19 Jan 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Strength Training From Plantigrade Foot Position on Motor Performance in Children With Diplegia
- ClinicalTrials.gov ID
- NCT04723641
- Acronym / sponsor ID
- Hana 5
- Conditions
- Diplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 26 Jan 2021 (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 functional strength training is mainly dealt with anti-gravity muscles and aiming at maximal carry over in day to day activities. The functional strength training can be given using resistance and it may be gravity, body weight, resistance bands and free weights. The exercises are specific to the muscle or muscle groups recruited during the functional activities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- intervention group received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Experimental | Other: functional training exercisesthey received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training. |
| control group | No intervention | –received a designed physical therapy program |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ranged from 7 to 10 years old.
- The degree of spasticity ranged from grade 1 to 2 hypertonia according to Modified Ashwarth Scale (MAS)
- Level II and III on GMFCS-ER
- They were able to understand and follow verbal instructions
Key exclusion criteria (1 listed)
- 1- visual or auditory problems. 2- Orthopedic surgery in the lower limb in the last 12 months before the study. 3- Fixed deformities in joints and bones of lower limbs. 4- Botox injection in the last six months before the study. 5- Children with any special medications affecting muscle functions (anti-spastic drugs).
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 |
|---|---|---|
| functional training exercisesprogressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training. | Other | STUDY GROUP |
Primary outcome
Gross motor functional measurement
Time frame: pre and after 3 months of intervention,, the higer score will represent the improvement
The GMFM is a standardized observational scale designed and validated to measure change in gross motor function over time in children with CP.
1 secondary outcome
Isometric muscle strength measurements
Time frame: pre and after 3 months of intervention,, increase in muscle will represent the improvement
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 20 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional training exercises in people with Diplegia, run by Badr University at 1 site in Egypt.
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 1 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 20 Apr 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 Egypt. 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?
Gross motor functional measurement (time frame: pre and after 3 months of intervention,, the higer score will represent the improvement). 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 20 Apr 2023.