Cerebral PalsyNCT04695639
Selective Motor Control and Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Identification of musculoskeletal and neuromuscular factors that affect the integrity and functional performance in children with cerebral palsy is very essential as it enables multidisciplinary rehabilitation team to design the proper intervention to improve functional performance and independence for those children. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hand Held Dynamometer and Quality of Upper Extremity Skill Test
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 5 May 2021
- Phase
- Observational
- 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 4 to 8 years
- All sexes
- Child
Study population: Participants will be recruited from the Outpatient Clinic of Faculty of Physical Therapy, Cairo University, Abo El-reesh Hospital and the Outpatient Clinic of Al-Minya General Hospital, Al-Minya Governorate.
Who may be able to join
- Age ranges from 4 to 8 years.
- Both genders.
- Diagnosis of spastic hemiparetic cerebral palsy.
- Level I-IV on Manual Ability Classification System.
- Spasticity grade 1 to 2 on Modified Ashworth Scale.
- Level I-III on Gross Motor Classification System .
Who cannot join
- Significant mental or psychological problems.
- Significant visual/auditory problem.
- Botox injection and/or surgery of the upper limb in the past 12 months.
- Fixed deformities in the affected upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Selective Motor Control and Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
Identification of musculoskeletal and neuromuscular factors that affect the integrity and functional performance in children with cerebral palsy is very essential as it enables multidisciplinary rehabilitation team to design the proper intervention to improve functional performance and independence for those children.
Read the detailed description
Limited literature is available regarding the relation between selective voluntary motor control and motor functions in children with cerebral palsy. Up to our knowledge this is the first study intending to investigate the influence of selective voluntary motor control on upper extremity function in children with spastic cerebral palsy. Therefore, the current study will be conducted to investigate the correlation between selective voluntary motor control and upper extremity functions in children with spastic hemiparetic cerebral palsy.
It is hypothesized that:-
- There is no relation between SVMC and upper limb function in children with spastic hemiparetic CP.
- There is no relation between upper extremity SVMC and hand grip strength in children with spastic hemiparetic CP.
- Conditions
- Cerebral Palsy
- Being tested
- Test of Arm Selective Control, Hand Held Dynamometer, Quality of Upper Extremity Skill Test
- Keywords
- Cerebral pals, selective voluntary motor control, upper extremity function, hand grip strength
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of Arm Selective ControlOther
It will be used to assess selective voluntary motor control. It is a reliable and valid evaluation tool used to quantify and describe selective voluntary motor control in children with spastic cerebral palsy. The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade, all in 'real time. Clinically this measure may guide the selection of medical, surgical, or therapy interventions and may improve outcome prognosis after brief training. Raters demonstrated excellent reliability in assessing upper extremity SVMC in a group of children with hemiplegic, diplegic, and quadriplegic CP using the Ttest of arm selective control
Hand Held DynamometerOther
Hand held dynamometer (Camry Digital Hand Dynamometer Grip Strength, Model EH101-37, China) will be used to assess hand grip strength of the affected upper extremity. It is generally small, portable and relatively cheap reliable measurement instruments to measure muscle strength of the arm and hand in children with spastic cerebral pasly. It is used to measure strength; maximal voluntary isometric contraction; objectively in kilograms, pounds or newtons. Such devices have been proven to have good to excellent reliability in different populations. It represents an easily accessible way to assess muscle weakness in children with cerebral palsy and the overall reliability is considered to be good.
Quality of Upper Extremity Skill TestOther
It will be used to assess function of the affected upper extremity. It is a reliable and valid outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. It is designed to be used with children who have neuromotor dysfunction with spasticity and has been validated with children from 18 months to 8 years of age.
| Study group | Role | What they receive |
|---|---|---|
| cohort group | A convenient sample of children with spastic hemiparetic CP of both genders will participate in this study. To avoid type II error, sample size calculation was performed prior to the study, based on data of pilot study, using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [Exact tests- correlational study, α=0.05, β=0.2, and effect size = 0.4] and revealed that the appropriate sample size for this study is N=46. Receives: Other: Test of Arm Selective Control; Other: Hand Held Dynamometer; Other: Quality of Upper Extremity Skill Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Arm Selective Control
The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade. Each joint is scored as a 0, 1, or 2. The joints of the affected limb are summed for a limb score for a total score. The maximum score is 16 per side, or 32 points in total (in hemiplegia assess the affected side only) with higher score indicates better performance. Admiration of the teat items and scoring will be conducted according to the scale user instructions.
Measured: 1/2/2021 to 30/4/2021
Secondary outcomes (2)
Hand Held Dynamometer
to evaluate hand grip strength
Measured: 1/2/2021 to 30/4/2021
Quality of Upper Extremity Skill Test
to assess upper limb function
Measured: 1/2/2021 to 30/4/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Feb 2021
- Primary completion30 Apr 2021
- Study completion5 May 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira M Abd-elmonem, PHD, Cairo University
- Investigators
- Maya Galal, Phd, Study director, Cairo UniversityRadwa Gomaa, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695639
- Sponsor's protocol ID
- Selective Motor Control
- Status last verified
- May 2021
- First submitted
- 3 Jan 2021
- Last updated
- 11 May 2021
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Selective Motor Control and Upper Extremity Functions in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04695639
- Acronym / sponsor ID
- Selective Motor Control
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral pals, selective voluntary motor control, upper extremity function, hand grip strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 5 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.
Identification of musculoskeletal and neuromuscular factors that affect the integrity and functional performance in children with cerebral palsy is very essential as it enables multidisciplinary rehabilitation team to design the proper intervention to improve functional performance and independence for those children.
Detailed description
Limited literature is available regarding the relation between selective voluntary motor control and motor functions in children with cerebral palsy. Up to our knowledge this is the first study intending to investigate the influence of selective voluntary motor control on upper extremity function in children with spastic cerebral palsy. Therefore, the current study will be conducted to investigate the correlation between selective voluntary motor control and upper extremity functions in children with spastic hemiparetic cerebral palsy.
It is hypothesized that:-
- There is no relation between SVMC and upper limb function in children with spastic hemiparetic CP.
- There is no relation between upper extremity SVMC and hand grip strength in children with spastic hemiparetic CP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort group | – | Other: Test of Arm Selective Control, Other: Hand Held Dynamometer, Other: Quality of Upper Extremity Skill TestA convenient sample of children with spastic hemiparetic CP of both genders will participate in this study. To avoid type II error, sample size calculation was performed prior to the study, based on data of pilot study, using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [Exact tests- correlational study, α=0.05, β=0.2, and effect size = 0.4] and revealed that the appropriate sample size for this study is N=46. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants will be recruited from the Outpatient Clinic of Faculty of Physical Therapy, Cairo University, Abo El-reesh Hospital and the Outpatient Clinic of Al-Minya General Hospital, Al-Minya Governorate.
Key inclusion criteria (6 listed)
- Age ranges from 4 to 8 years.
- Both genders.
- Diagnosis of spastic hemiparetic cerebral palsy.
- Level I-IV on Manual Ability Classification System.
- Spasticity grade 1 to 2 on Modified Ashworth Scale.
Key exclusion criteria (4 listed)
- Significant mental or psychological problems.
- Significant visual/auditory problem.
- Botox injection and/or surgery of the upper limb in the past 12 months.
- Fixed deformities in the affected upper extremity.
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 |
|---|---|---|
| Test of Arm Selective ControlIt will be used to assess selective voluntary motor control. It is a reliable and valid evaluation tool used to quantify and describe selective voluntary motor control in children with spastic cerebral palsy. The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade, all in 'real time. Clinically this measure may guide the selection of medical, surgical, or therapy interventions and may improve outcome prognosis after brief training. Raters demonstrated excellent reliability in assessing upper extremity SVMC in a group of children with hemiplegic, diplegic, and quadriplegic CP using the Ttest of arm selective control | Other | cohort group |
| Hand Held DynamometerHand held dynamometer (Camry Digital Hand Dynamometer Grip Strength, Model EH101-37, China) will be used to assess hand grip strength of the affected upper extremity. It is generally small, portable and relatively cheap reliable measurement instruments to measure muscle strength of the arm and hand in children with spastic cerebral pasly. It is used to measure strength; maximal voluntary isometric contraction; objectively in kilograms, pounds or newtons. Such devices have been proven to have good to excellent reliability in different populations. It represents an easily accessible way to assess muscle weakness in children with cerebral palsy and the overall reliability is considered to be good. | Other | cohort group |
| Quality of Upper Extremity Skill TestIt will be used to assess function of the affected upper extremity. It is a reliable and valid outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. It is designed to be used with children who have neuromotor dysfunction with spasticity and has been validated with children from 18 months to 8 years of age. | Other | cohort group |
Primary outcome
Test of Arm Selective Control
Time frame: 1/2/2021 to 30/4/2021
The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade. Each joint is scored as a 0, 1, or 2. The joints of the affected limb are summed for a limb score for a total score. The maximum score is 16 per side, or 32 points in total (in hemiplegia assess the affected side only) with higher score indicates better performance. Admiration of the teat items and scoring will be conducted according to the scale user instructions.
2 secondary outcomes
Hand Held Dynamometer
Time frame: 1/2/2021 to 30/4/2021
Quality of Upper Extremity Skill Test
Time frame: 1/2/2021 to 30/4/2021
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 11 May 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.
Maya Galal, Phd study director
Cairo University
Radwa Gomaa 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?
An observational study of 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 6 inclusion and 4 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 11 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 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?
Test of Arm Selective Control (time frame: 1/2/2021 to 30/4/2021). 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 11 May 2021.