Cerebral PalsyNCT04117282
Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia
A study testing gait training in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Improving the quality of gait in the diplegic children is a major concern in the rehabilitation program. Thirty children with spastic diplegia were distributed equally into 2 groups, group A (control) and group B (study). Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2019to 7 May 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 30 diplegic children of both gender aged from 6 to 8,
- GMFCS levelII and II . has gait defecits including percentage of gait cycles.
Who cannot join
- recent surgical intervention.
- orthopedic deformity in lower limbs.
- sever vision or hearing problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy,Cairo University
Cairo, Giza Governorate, 02
About this study
Official title: Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia (Using 2 D Gait Analysis)
Improving the quality of gait in the diplegic children is a major concern in the rehabilitation program. Thirty children with spastic diplegia were distributed equally into 2 groups, group A (control) and group B (study). Group A had received the traditional physical therapy program for 30 minutes and 30 minutes traditional gait training, while group B had received 30 minutes gait training with antigravity shoes in addition to the traditional exercise program for 30 minutes, percentage of stance and swing phase of gait were measured by 2 D gait analysis for children of both groups pre and after 3 successive months of treatment program, also function level of gait were assessed pre and post treatment by GMFCS .
Read the detailed description
Thirty children with spastic diplegia, their age ranged from 6 to 8 years old, were distributed equally into 2 groups: group A (control) and group B (study) They could walk with limitation or holding on according to GMFCS (level II \&III). (Palisano et al., 2008). Increased time for stance phase and decreased swing phase time was recorded when evaluated by 2D gait analysis.
Control group (A):
The children in this group had received traditional physical therapy exercise program designed for those cases for 30 minutes in addition to gait training program for 30 minutes / day, 3 times / week for 3 successive months.
Study group (B):
The children in this group received the same traditional exercise program for 30 minutes in addition to gait training program for 30 minutes using the antigravity shoes.
evaluation was done before and after treatment. treatment include traditional exercises for gait and balance for both groups in addition to use the antigravity shoes for study group.
- Conditions
- Cerebral Palsy
- Being tested
- gait training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait trainingOther
Also called gait rehabilitation
training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training) Receives: Other: gait training |
| study group | Experimental | 15 diplegic child received the same exercise program including the use of the antigravity shoes for gait training (30 minutes exercises + 30 minutes gait training) Receives: Other: gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait time percentage for right lower limb
the time of stance and swing phases as a percentage for right lower limb during gait
Measured: after 3 months of treatment
gait time percentage of left lower limb
the time of stance and swing phases as a percentage for left lower limb during gait
Measured: after 3 months of treatment
Secondary outcomes (1)
level of function through GMFCS
changing the level of function by using the GMFCS
Measured: before and after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start3 Feb 2019
- Primary completion5 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- 2 groups study and control
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohamed Ibrahim, Cairo University
- Investigators
- Nahla Mohamed, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117282
- Sponsor's protocol ID
- pediatric physical therapy
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 7 Oct 2019
- Results posted
- 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 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia (Using 2 D Gait Analysis)
- ClinicalTrials.gov ID
- NCT04117282
- Acronym / sponsor ID
- pediatric physical therapy
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Feb 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 7 Oct 2019 (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.
Improving the quality of gait in the diplegic children is a major concern in the rehabilitation program. Thirty children with spastic diplegia were distributed equally into 2 groups, group A (control) and group B (study). Group A had received the traditional physical therapy program for 30 minutes and 30 minutes traditional gait training, while group B had received 30 minutes gait training with antigravity shoes in addition to the traditional exercise program for 30 minutes, percentage of stance and swing phase of gait were measured by 2 D gait analysis for children of both groups pre and after 3 successive months of treatment program, also function level of gait were assessed pre and post treatment by GMFCS .
Detailed description
Thirty children with spastic diplegia, their age ranged from 6 to 8 years old, were distributed equally into 2 groups: group A (control) and group B (study) They could walk with limitation or holding on according to GMFCS (level II \&III). (Palisano et al., 2008). Increased time for stance phase and decreased swing phase time was recorded when evaluated by 2D gait analysis.
Control group (A):
The children in this group had received traditional physical therapy exercise program designed for those cases for 30 minutes in addition to gait training program for 30 minutes / day, 3 times / week for 3 successive months.
Study group (B):
The children in this group received the same traditional exercise program for 30 minutes in addition to gait training program for 30 minutes using the antigravity shoes.
evaluation was done before and after treatment. treatment include traditional exercises for gait and balance for both groups in addition to use the antigravity shoes for study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups study and control
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: gait training15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training) |
| study group | Experimental | Other: gait training15 diplegic child received the same exercise program including the use of the antigravity shoes for gait training (30 minutes exercises + 30 minutes gait training) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 30 diplegic children of both gender aged from 6 to 8,
- GMFCS levelII and II . has gait defecits including percentage of gait cycles.
Key exclusion criteria (3 listed)
- recent surgical intervention.
- orthopedic deformity in lower limbs.
- sever vision or hearing problems.
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 |
|---|---|---|
| gait trainingAlso: gait rehabilitationtraining for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait | Other | control group, study group |
Primary outcome
gait time percentage for right lower limb
Time frame: after 3 months of treatment
the time of stance and swing phases as a percentage for right lower limb during gait
gait time percentage of left lower limb
Time frame: after 3 months of treatment
the time of stance and swing phases as a percentage for left lower limb during gait
1 secondary outcome
level of function through GMFCS
Time frame: before and after 3 months of treatment
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 7 Oct 2019.
- 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.
Nahla Mohamed, lecturer principal investigator
Cairo 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 gait training in people with Cerebral Palsy, run by Cairo 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 2 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 7 Oct 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 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?
gait time percentage for right lower limb (time frame: after 3 months of treatment). The study lists 2 primary outcomes in all. 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 7 Oct 2019.