Developmental DelayNCT05392296
Effects of Power Ball on Grip Strength in Children With Developmental Delay.
A study testing Power ball and isometric hand grip strengthening exercises in people with Developmental Delay, run by Riphah International University at 1 site in Pakistan.
Trial summary
Developmental delay refers to the child who does not perform the normal milestones as other children accomplish in the same age within time or somehow late but can achieve them. While if the delay is found in two or more than two areas of the developmental skill it is known as Global Developmental Delay (GDD). Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Developmental Delay
- What is being tested?
- Power ball and isometric hand grip strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 31 Oct 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 7-12 years
- Both genders (male /female)
- Moderate developmental delay
- Affected fine motor skill
Who cannot join
- With another neurological conditions(cerebral palsy, down's syndrome, Autism)
- Genetic disorder-
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rising Sun Institute For Special Children, Lahore
Lahore, Punjab Province, 54000
About this study
Developmental delay refers to the child who does not perform the normal milestones as other children accomplish in the same age within time or somehow late but can achieve them. While if the delay is found in two or more than two areas of the developmental skill it is known as Global Developmental Delay (GDD). It is divided into mild, moderate and severe developmental delay contributed by many other causes like prenatal, perinatal, postnatal and socioeconomic factors. The objective of the study is to determine the effects of power ball on grip strengthening children with developmental delay. In this study, we will randomly assigned 28 children into two groups, One group will be control group getting the conventional treatment (isometric hand grip training exercises) and other will be experimental group getting the power ball training with conventional treatment. During the sessions hand held dynamometer is use to check the grip strength. By using power ball grip strength in children with Developmental Delay can be improved.
- Conditions
- Developmental Delay
- Being tested
- Power ball, isometric hand grip strengthening exercises
- Keywords
- power ball, Strengthening exercises, Hand grip, Developmental delay, Dynamometer
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power ballOther
experimental group getting the power ball training with conventional treatment.
isometric hand grip strengthening exercisesOther
conventional treatment (isometric hand grip training exercises)
| Study group | Role | What they receive |
|---|---|---|
| Power ball | Experimental | experimental group getting the power ball training with conventional treatment Receives: Other: Power ball; Other: isometric hand grip strengthening exercises |
| Conventional | Active comparator | group will be control group getting the conventional treatment (isometric hand grip training exercises) Receives: Other: isometric hand grip strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Grip strength by Hand held Dynamometer
A small portable device is held by the examiner and placed against the patient's limb during a maximal isometric contraction. A hand held dynamometer, however, takes the force a patient generates and transmits it through a transducer, quantifies the force, and then presents the data in a digital format. Health professionals can use this muscle strength testing equipment to measure muscle strength efficiently and effectively across the board. The purpose of using a hand dynamometer is to measure the maximum isometric strength of the hand and forearm muscles. The hand dynamometer can be adjusted for hand size and must be calibrated regularly for consistent results
Measured: Baseline, 7th and 14th day
Change in ABILHAND-KIDS tool scores
The ABILHAND KIDS was originally developed by using the Rasch measurement model. It allows to convert ordinal score into linear measure located on unidimensional score.
Procedure Parents are asked to fill the questionnaire according to child ability to do manual task ,ease in doing fine motor task and difficulty in performing activities, when the task are done1 Without other technical and human help(even if child actually uses help in daily life) 2 Irrespective of the limb actually used to do activity 3 Whatever strategy was used(any compensation is allowed
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Mar 2022
- Primary completion15 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392296
- Sponsor's protocol ID
- REC/RCR & AHS/22/0703
- Status last verified
- Jan 2023
- First submitted
- 23 May 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choo YY, Agarwal P, How CH, Yeleswarapu SP. Developmental delay: identification and management at primary care level. Singapore Med J. 2019 Mar;60(3):119-123. doi: 10.11622/smedj.2019025.
PubMed 30997518Mithyantha R, Kneen R, McCann E, Gladstone M. Current evidence-based recommendations on investigating children with global developmental delay. Arch Dis Child. 2017 Nov;102(11):1071-1076. doi: 10.1136/archdischild-2016-311271.
PubMed 29054862Vitrikas K, Savard D, Bucaj M. Developmental Delay: When and How to Screen. Am Fam Physician. 2017 Jul 1;96(1):36-43.
PubMed 28671370Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2.
PubMed 24488746Yoo S, Park SK, Yoon S, Lim HS, Ryu J. Comparison of Proprioceptive Training and Muscular Strength Training to Improve Balance Ability of Taekwondo Poomsae Athletes: A Randomized Controlled Trials. J Sports Sci Med. 2018 Aug 14;17(3):445-454. eCollection 2018 Sep.
PubMed 30116118
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Power Ball on Grip Strength in Children With Developmental Delay.
- ClinicalTrials.gov ID
- NCT05392296
- Acronym / sponsor ID
- REC/RCR & AHS/22/0703
- Conditions
- Developmental Delay
- Keywords
- power ball, Strengthening exercises, Hand grip, Developmental delay, Dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 26 May 2022 (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.
Developmental delay refers to the child who does not perform the normal milestones as other children accomplish in the same age within time or somehow late but can achieve them. While if the delay is found in two or more than two areas of the developmental skill it is known as Global Developmental Delay (GDD). It is divided into mild, moderate and severe developmental delay contributed by many other causes like prenatal, perinatal, postnatal and socioeconomic factors. The objective of the study is to determine the effects of power ball on grip strengthening children with developmental delay. In this study, we will randomly assigned 28 children into two groups, One group will be control group getting the conventional treatment (isometric hand grip training exercises) and other will be experimental group getting the power ball training with conventional treatment. During the sessions hand held dynamometer is use to check the grip strength. By using power ball grip strength in children with Developmental Delay can be improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power ball | Experimental | Other: Power ball, Other: isometric hand grip strengthening exercisesexperimental group getting the power ball training with conventional treatment |
| Conventional | Active comparator | Other: isometric hand grip strengthening exercisesgroup will be control group getting the conventional treatment (isometric hand grip training exercises) |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 7-12 years
- Both genders (male /female)
- Moderate developmental delay
- Affected fine motor skill
Key exclusion criteria (2 listed)
- With another neurological conditions(cerebral palsy, down's syndrome, Autism)
- Genetic disorder-
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 |
|---|---|---|
| Power ballexperimental group getting the power ball training with conventional treatment. | Other | Power ball |
| isometric hand grip strengthening exercisesconventional treatment (isometric hand grip training exercises) | Other | Conventional, Power ball |
Primary outcome
Change in Grip strength by Hand held Dynamometer
Time frame: Baseline, 7th and 14th day
A small portable device is held by the examiner and placed against the patient's limb during a maximal isometric contraction. A hand held dynamometer, however, takes the force a patient generates and transmits it through a transducer, quantifies the force, and then presents the data in a digital format. Health professionals can use this muscle strength testing equipment to measure muscle strength efficiently and effectively across the board. The purpose of using a hand dynamometer is to measure the maximum isometric strength of the hand and forearm muscles. The hand dynamometer can be adjusted for hand size and must be calibrated regularly for consistent results
Change in ABILHAND-KIDS tool scores
Time frame: Baseline and 1 month
The ABILHAND KIDS was originally developed by using the Rasch measurement model. It allows to convert ordinal score into linear measure located on unidimensional score. Procedure Parents are asked to fill the questionnaire according to child ability to do manual task ,ease in doing fine motor task and difficulty in performing activities, when the task are done1 Without other technical and human help(even if child actually uses help in daily life) 2 Irrespective of the limb actually used to do activity 3 Whatever strategy was used(any compensation is allowed
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 5 Jan 2023.
- Background: PubMed 30997518Choo YY, Agarwal P, How CH, Yeleswarapu SP. Developmental delay: identification and management at primary care level. Singapore Med J. 2019 Mar;60(3):119-123. doi: 10.11622/smedj.2019025.
- Background: PubMed 29054862Mithyantha R, Kneen R, McCann E, Gladstone M. Current evidence-based recommendations on investigating children with global developmental delay. Arch Dis Child. 2017 Nov;102(11):1071-1076. doi: 10.1136/archdischild-2016-311271.
- Background: PubMed 28671370Vitrikas K, Savard D, Bucaj M. Developmental Delay: When and How to Screen. Am Fam Physician. 2017 Jul 1;96(1):36-43.
- Background: PubMed 24488746Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2.
- Background: PubMed 30116118Yoo S, Park SK, Yoon S, Lim HS, Ryu J. Comparison of Proprioceptive Training and Muscular Strength Training to Improve Balance Ability of Taekwondo Poomsae Athletes: A Randomized Controlled Trials. J Sports Sci Med. 2018 Aug 14;17(3):445-454. eCollection 2018 Sep.
- 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.
Sidra Afzal, PP-DPT principal investigator
Riphah International 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 Power ball and isometric hand grip strengthening exercises in people with Developmental Delay, run by Riphah International University at 1 site in Pakistan.
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 2 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 5 Jan 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 Pakistan. 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?
Change in Grip strength by Hand held Dynamometer (time frame: Baseline, 7th and 14th day). 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?
On the ClinicalTrials.gov record for NCT05392296, which also lists 5 linked publications.
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 5 Jan 2023.