Cerebral PalsyNCT04907448
Isokinetic Strength Training in Children With Hemiparetic Cerebral Palsy
A study testing Physical Therapy in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study endeavored to assess the effect of an isokinetic strength training (IsoK-ST) program on weight-bearing symmetry, gait-symmetry, and dynamic balance in children with hemiparetic cerebral palsy (HCP). Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Dec 2018to 9 Jan 2020
- 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
- Hemiparetic cerebral palsy
- Age 8-16 years
- Motor function level I or II according to the Gross Motor Function Classification System.
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Who cannot join
- Structural deformities
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders interfering with the ability to engage in exercise training.
- Hemispatial neglect.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Weight-bearing- and Walking-symmetry and Dynamic Balance Using an Isokinetic Strength Training Protocol in Children With Hemiparetic Cerebral Palsy
This study endeavored to assess the effect of an isokinetic strength training (IsoK-ST) program on weight-bearing symmetry, gait-symmetry, and dynamic balance in children with hemiparetic cerebral palsy (HCP). Thirty-six children with HCP were randomly allocated to the IsoK-ST group (n = 18, received their usual physical rehabilitation program plus an IsoK-ST program) or the Control group (n =18, received usual physical rehabilitation alone). Both groups were assessed for weight-bearing symmetry, gait-symmetry, and dynamic balance before and after treatment.
Read the detailed description
Thirty-six children with HCP were recruited from the Physical Therapy Outpatient Clinic of Collee of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 8 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had structural nonreducible deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, sensory-perceptual disorders, unstable convulsions, cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
- Weight-bearing symmetry index: The weight-bearing symmetry index for the rearfoot and forefoot segments were assessed through a pressure analysis system
- Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAIT Rite system.
- Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
The IsoK-ST and control groups received their usual physical rehabilitation program for 45 minutes, three times a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The IsoK-ST consisted of 3 sets (5-10 repetitions) of maximal concentric contraction of knee extensors and flexors on the affected side at angular speeds of 90, 120, 180, and 240 deg./sec., with intervals of rest for two minutes after each selected speed. The IsoK-ST workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-dowm.
- Conditions
- Cerebral Palsy
- Being tested
- Physical Therapy
- 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 TherapyOther
The IsoK-ST group received their usual physical therapy program for 45 minutes, three times a week for eight successive weeks, which comprised advanced balance training, weight-bearing exercises, gait training, postural and flexibility exercises, and strength training exercises.
Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight successive weeks.
The control group received the usual physical rehabilitation program only for 45 minutes, three times a week for eight successive weeks.
| Study group | Role | What they receive |
|---|---|---|
| IsoK-ST group | Experimental | Participants in this group received the usual physical rehabilitation program in addition to an IsoK-ST program. Receives: Other: Physical Therapy |
| Control group | Active comparator | Participants in this group received the usual physical rehabilitation program only. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-bearing symmetry
The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.
Measured: 2 months
Gait-symmetry indices
Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through the portable GAIT Rite system
Measured: 2 months
Dynamic balance
The directional (forward, backward, paretic, and non-paretic) and overall dynamic limits of stability were assessed through the Biodex balance system.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start23 Dec 2018
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
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
- A prospective pre-test post-test randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907448
- Sponsor's protocol ID
- RHPT/0018/0062
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Weight-bearing- and Walking-symmetry and Dynamic Balance Using an Isokinetic Strength Training Protocol in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04907448
- Acronym / sponsor ID
- RHPT/0018/0062
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Dec 2018 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 28 May 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.
This study endeavored to assess the effect of an isokinetic strength training (IsoK-ST) program on weight-bearing symmetry, gait-symmetry, and dynamic balance in children with hemiparetic cerebral palsy (HCP). Thirty-six children with HCP were randomly allocated to the IsoK-ST group (n = 18, received their usual physical rehabilitation program plus an IsoK-ST program) or the Control group (n =18, received usual physical rehabilitation alone). Both groups were assessed for weight-bearing symmetry, gait-symmetry, and dynamic balance before and after treatment.
Detailed description
Thirty-six children with HCP were recruited from the Physical Therapy Outpatient Clinic of Collee of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 8 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had structural nonreducible deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, sensory-perceptual disorders, unstable convulsions, cardiopulmonary problems preventing them from performing high-intense exercise training.
Outcome measures
- Weight-bearing symmetry index: The weight-bearing symmetry index for the rearfoot and forefoot segments were assessed through a pressure analysis system
- Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAIT Rite system.
- Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.
The IsoK-ST and control groups received their usual physical rehabilitation program for 45 minutes, three times a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The IsoK-ST consisted of 3 sets (5-10 repetitions) of maximal concentric contraction of knee extensors and flexors on the affected side at angular speeds of 90, 120, 180, and 240 deg./sec., with intervals of rest for two minutes after each selected speed. The IsoK-ST workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-dowm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective pre-test post-test randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| IsoK-ST group | Experimental | Other: Physical TherapyParticipants in this group received the usual physical rehabilitation program in addition to an IsoK-ST program. |
| Control group | Active comparator | Other: Physical TherapyParticipants in this group received the usual physical rehabilitation program only. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Hemiparetic cerebral palsy
- Age 8-16 years
- Motor function level I or II according to the Gross Motor Function Classification System.
- Spasticity level 1 or 1+ according to the Modified Ashworth Scale
Key exclusion criteria (5 listed)
- Structural deformities
- Musculoskeletal or neural surgery in the last year
- BOTOX injection in the last 6 months.
- Cardiopulmonary disorders interfering with the ability to engage in exercise training.
- Hemispatial neglect.
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 TherapyThe IsoK-ST group received their usual physical therapy program for 45 minutes, three times a week for eight successive weeks, which comprised advanced balance training, weight-bearing exercises, gait training, postural and flexibility exercises, and strength training exercises. Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight successive weeks. The control group received the usual physical rehabilitation program only for 45 minutes, three times a week for eight successive weeks. | Other | Control group, IsoK-ST group |
Primary outcome
Weight-bearing symmetry
Time frame: 2 months
The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.
Gait-symmetry indices
Time frame: 2 months
Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through the portable GAIT Rite system
Dynamic balance
Time frame: 2 months
The directional (forward, backward, paretic, and non-paretic) and overall dynamic limits of stability were assessed through the Biodex balance system.
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 May 2021.
- 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.
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 Physical Therapy in people with Cerebral Palsy, run by Cairo University at 1 site in Saudi Arabia.
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 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: finished, as of the sponsor's last update on 28 May 2021. 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 Saudi Arabia. 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?
Weight-bearing symmetry (time frame: 2 months). The study lists 3 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 28 May 2021.