Hemiplegic Cerebral PalsyNCT05490758
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
A study testing sensorimotor training and constraint induced movement therapy in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the work was to find out the effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- sensorimotor training and constraint induced movement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 18 May 2022to 28 Jun 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- subjects who were fully oriented
- children diagnosed with hemiplegic cerebral palsy
- no history of intramuscular botulinum injections past one year
Who cannot join
- children with epilepsy
- gross deformity of upper limb
- children with contractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
The aim of the work was to find out the effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy.
Read the detailed description
The significance of this study is that there was paucity of literature in finding the comparative effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy. The aim is to find out the effects of sensorimotor training on motor functioning of the upper extremity in comparison of constraint induced movement therapy.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- sensorimotor training, constraint induced movement therapy
- Keywords
- sensorimotor training, motor function, constraint induced movement therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorimotor trainingOther
sensorimotor training include activities like play with dough, peg games, puzzles for 5 days a week for 4 week.
constraint induced movement therapyOther
constraint induced movement therapy in which arm was constraint for 6 hours a day for 5 days a week for 4 week.
| Study group | Role | What they receive |
|---|---|---|
| sensorimotor training | Experimental | sensorimotor training group did sensorimotor activities e.g play with dough,peg games 5 days a week for 4 weeks. Receives: Other: sensorimotor training |
| constraint induced movement therapy | Experimental | constraint induced movement therapy group in which affected arm was constraint for 6 hours a day for 5 days a week for 4 weeks. Receives: Other: constraint induced movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
nine hole peg test
nine hole peg test to check hand dexterity and grip. The patient is seated at a table with a container holding nine pegs and a wood/plastic block containing nine empty holes and asked to put the nine pegs in nine holes in a block one by one and then remove the pegs one at a time from the holes and the time is recorded. patient should do the test with both hands independently.
Measured: 4 weeks
Secondary outcomes (1)
manual ability classification system
it describes how CP child uses his or her hands to handle objects in daily activities with qualitative analysis by care taker, it has five levels. in level 1 child holds objects easily and succesfully. in level 2 child handles most object but with some reduced quality or speed. in level 3 the objects are handled with difficulty and child needs help to prepare or modify activities. in level 4 child handles a limited selection of easily managed objects and always requires some help from others. in level 5 child is not able to handle objects or to complete even simple actions with their hands.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start18 May 2022
- Primary completion15 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490758
- Sponsor's protocol ID
- REC/RCR & AHS/22/0718
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
PubMed 30932166Santana CAS, Tudella E, Rocha NACF, de Campos AC. Lower Limb Sensorimotor Training (LoSenseT) for Children and Adolescents with Cerebral Palsy: A Brief Report of a Feasibility Randomized Protocol. Dev Neurorehabil. 2021 May;24(4):276-286. doi: 10.1080/17518423.2020.1858458. Epub 2021 Jan 3.
PubMed 33393402Samaei A, Mirshoja MS, Khalili MA. Comparison of Sensorimotor Retraining Methods by Movement Therapy Based on Limitations in Upper Extremity Function in Patients with Chronic Stroke. INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND ALLIED SCIENCES. 2016;5(2):510-+.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05490758
- Acronym / sponsor ID
- REC/RCR & AHS/22/0718
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- sensorimotor training, motor function, constraint induced movement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 8 Aug 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.
The aim of the work was to find out the effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy.
Detailed description
The significance of this study is that there was paucity of literature in finding the comparative effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy. The aim is to find out the effects of sensorimotor training on motor functioning of the upper extremity in comparison of constraint induced movement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensorimotor training | Experimental | Other: sensorimotor trainingsensorimotor training group did sensorimotor activities e.g play with dough,peg games 5 days a week for 4 weeks. |
| constraint induced movement therapy | Experimental | Other: constraint induced movement therapyconstraint induced movement therapy group in which affected arm was constraint for 6 hours a day for 5 days a week for 4 weeks. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- subjects who were fully oriented
- children diagnosed with hemiplegic cerebral palsy
- no history of intramuscular botulinum injections past one year
Key exclusion criteria (3 listed)
- children with epilepsy
- gross deformity of upper limb
- children with contractures
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 |
|---|---|---|
| sensorimotor trainingsensorimotor training include activities like play with dough, peg games, puzzles for 5 days a week for 4 week. | Other | sensorimotor training |
| constraint induced movement therapyconstraint induced movement therapy in which arm was constraint for 6 hours a day for 5 days a week for 4 week. | Other | constraint induced movement therapy |
Primary outcome
nine hole peg test
Time frame: 4 weeks
nine hole peg test to check hand dexterity and grip. The patient is seated at a table with a container holding nine pegs and a wood/plastic block containing nine empty holes and asked to put the nine pegs in nine holes in a block one by one and then remove the pegs one at a time from the holes and the time is recorded. patient should do the test with both hands independently.
1 secondary outcome
manual ability classification system
Time frame: 4 weeks
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 8 Aug 2022.
- Background: PubMed 30932166Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
- Background: PubMed 33393402Santana CAS, Tudella E, Rocha NACF, de Campos AC. Lower Limb Sensorimotor Training (LoSenseT) for Children and Adolescents with Cerebral Palsy: A Brief Report of a Feasibility Randomized Protocol. Dev Neurorehabil. 2021 May;24(4):276-286. doi: 10.1080/17518423.2020.1858458. Epub 2021 Jan 3.
- BackgroundSamaei A, Mirshoja MS, Khalili MA. Comparison of Sensorimotor Retraining Methods by Movement Therapy Based on Limitations in Upper Extremity Function in Patients with Chronic Stroke. INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND ALLIED SCIENCES. 2016;5(2):510-+.
- 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.
Wajiha Shahid, PhD 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 sensorimotor training and constraint induced movement therapy in people with Hemiplegic Cerebral Palsy, 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 3 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 8 Aug 2022. 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?
nine hole peg test (time frame: 4 weeks). 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 NCT05490758, which also lists 3 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 8 Aug 2022.