Cerebral PalsyNCT05106829
Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children
A study testing Physical therapy program with treadmill training without using of ankle weights. and Physical therapy program with treadmill training with using of ankle weights. in people with Cerebral Palsy, run by Beni-Suef University.
Trial summary
The purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical therapy program with treadmill training without using of ankle weights. and Physical therapy program with treadmill training with using of ankle weights.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Jan 2022
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist.
- 3-Spasticity grades ranged from 1 to +1 according to modified Ashworth. 4-Balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the Biodex stability system.
- 5-Independent standing and walking. 6-Ability to follow simple verbal commands and instructions
Who cannot join
- Auditory or visual defects or any perceptual defects.
- Fixed deformities on both upper or/ lower limbs.
- Botox injection.
- Cardiovasucular disease.
- Surgery within the previous 24 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Treadmill Training Combined With Ankle Weights on Balance in Spastic Cerebral Palsied Children.
The purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.
Read the detailed description
Cerebral palsy defined as a non-progressive, non-hereditary lesion of the cerebral cortex resulting in postural and motion disturbances. Spastic cerebral palsied children have deficits in the selection of appropriate sensory inputs for postural control. Balance is a complex motor skill often referred to as postural control which is the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over the base of support. Treadmill gait training supporting the body weight which simulates walking on flat land is prescribed in rehabilitation of spastic cerebral palsy to improve their balance or to reduce their gait disturbance. Several studies support the use of ankle weights during treadmill gait training to reinforce muscle strength and, improve the symmetry of gait while, there is no research conducted on balance in spastic cerebral palsied children. Hence, there is need to study the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.
Fourty children with spastic hemiparetic cerebral palsied children (based on power analysis) from both sexes (6-9 years) will be recruited from different private pediatric physical therapy clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in designed physical therapy program in addition to gait training on treadmill with full weight bearing without using of ankle weights. Study group will be participated in the same designed physical therapy program received by the control group in addition to gait training on treadmill with ankle weights on the affected side ankle.
- Conditions
- Cerebral Palsy
- Being tested
- Physical therapy program with treadmill training without using of ankle weights., Physical therapy program with treadmill training with using of ankle weights.
- Keywords
- Treadmill, Biodex Balance System, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy program with treadmill training without using of ankle weights.Other
The physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill without ankle weights.
Physical therapy program with treadmill training with using of ankle weights.Other
he physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill with ankle weights.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy program with treadmill training without using of ankle weights. | Active comparator | Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill for 30 min./ session. Receives: Other: Physical therapy program with treadmill training without using of ankle weights. |
| Physical therapy program with treadmill training with using of ankle weights. | Experimental | Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill with ankle weights for 30 min./ session. Receives: Other: Physical therapy program with treadmill training with using of ankle weights. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
Measured: Up to 8 weeks
Muscle strength
Handheld dynamometer (Lafayette) will be used to record dorsiflexors force in pounds (Lbs)
Measured: Up to 8 weeks
Secondary outcomes (1)
Functional balance assessment
Pediatric Balance Scale will be used to assess functional balance. It contains 14 items (Sitting to standing-Standing to sitting-Transfers-Standing unsupported-Sitting unsupported-Standing with eyes closed-Standing with feet together-Standing with one foot in front-Standing on one foot-Turning 360 degrees-Turning to look behind-Retrieving object from floor-Placing alternate foot on stool-Reaching forward with outstretched arm) that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
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 Beni-Suef 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
- Physical therapy and ankle weights.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wagdy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106829
- Sponsor's protocol ID
- P.T.REC/012/003112
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treadmill Training Combined With Ankle Weights on Balance in Spastic Cerebral Palsied Children.
- ClinicalTrials.gov ID
- NCT05106829
- Acronym / sponsor ID
- P.T.REC/012/003112
- Conditions
- Cerebral Palsy
- Keywords
- Treadmill, Biodex Balance System, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 4 Nov 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 purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.
Detailed description
Cerebral palsy defined as a non-progressive, non-hereditary lesion of the cerebral cortex resulting in postural and motion disturbances. Spastic cerebral palsied children have deficits in the selection of appropriate sensory inputs for postural control. Balance is a complex motor skill often referred to as postural control which is the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over the base of support. Treadmill gait training supporting the body weight which simulates walking on flat land is prescribed in rehabilitation of spastic cerebral palsy to improve their balance or to reduce their gait disturbance. Several studies support the use of ankle weights during treadmill gait training to reinforce muscle strength and, improve the symmetry of gait while, there is no research conducted on balance in spastic cerebral palsied children. Hence, there is need to study the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.
Fourty children with spastic hemiparetic cerebral palsied children (based on power analysis) from both sexes (6-9 years) will be recruited from different private pediatric physical therapy clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in designed physical therapy program in addition to gait training on treadmill with full weight bearing without using of ankle weights. Study group will be participated in the same designed physical therapy program received by the control group in addition to gait training on treadmill with ankle weights on the affected side ankle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Physical therapy and ankle weights.
| Arm | Type | Receives |
|---|---|---|
| Physical therapy program with treadmill training without using of ankle weights. | Active comparator | Other: Physical therapy program with treadmill training without using of ankle weights.Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill for 30 min./ session. |
| Physical therapy program with treadmill training with using of ankle weights. | Experimental | Other: Physical therapy program with treadmill training with using of ankle weights.Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill with ankle weights for 30 min./ session. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1-Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist.
- 3-Spasticity grades ranged from 1 to +1 according to modified Ashworth. 4-Balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the Biodex stability system.
- 5-Independent standing and walking. 6-Ability to follow simple verbal commands and instructions
Key exclusion criteria (5 listed)
- Auditory or visual defects or any perceptual defects.
- Fixed deformities on both upper or/ lower limbs.
- Botox injection.
- Cardiovasucular disease.
- Surgery within the previous 24 months.
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 |
|---|---|---|
| Physical therapy program with treadmill training without using of ankle weights.The physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill without ankle weights. | Other | Physical therapy program with treadmill training without using of ankle weights. |
| Physical therapy program with treadmill training with using of ankle weights.he physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill with ankle weights. | Other | Physical therapy program with treadmill training with using of ankle weights. |
Primary outcome
Balance
Time frame: Up to 8 weeks
Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.
Muscle strength
Time frame: Up to 8 weeks
Handheld dynamometer (Lafayette) will be used to record dorsiflexors force in pounds (Lbs)
1 secondary outcome
Functional balance assessment
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy program with treadmill training without using of ankle weights. and Physical therapy program with treadmill training with using of ankle weights. in people with Cerebral Palsy, run by Beni-Suef University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Wagdy, PH.D (01008079576, Eman.wagdy@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Up to 8 weeks). 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 4 Nov 2021.