Cerebral PalsyNCT05491863
Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy
A study testing conservative physiotherapy plan and trunk stability exercise plan in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Rationale of this research is to evaluate the outcome of trunk stabilizing exercises on the fine motor skills of subjects with hemiplegic CP. The significance of this study is to identify how much core stability exercises improve hand function. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- conservative physiotherapy plan and trunk stability exercise plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2021to 25 May 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both male and female were included
- Age group 6 to 18 years.
- Medical diagnosis of hemiplegic cerebral palsy assured.
- Unilateral Movement deficit (less than 2.5) on amount of use scale on MAL (motor activity log).
- Level 1 to 3 on manual ability classification system (MACS).
- Mild to moderate spasticity of upper extremity (MAS grade 1 to 2.)
- GMCS level I-II.
- Subjects were cognitively capable and competent to follow the instructions
Who cannot join
- Patients with altered conscious level.
- Previous surgery or pain in upper limbs.
- Rigid contracture and fixed deformities in the spine
- Auditory / vision problem.
- Previous Botulinum Toxin-A injections in upper limb.
- Cardio-respiratory problem
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rising sun institute for special children
Lahore, Punjab Province, 54792
About this study
Rationale of this research is to evaluate the outcome of trunk stabilizing exercises on the fine motor skills of subjects with hemiplegic CP. The significance of this study is to identify how much core stability exercises improve hand function. This study will help gather evidence on the practice of core stabilizing exercises to improve hand function so that it can help both physicians and patients.
Read the detailed description
Cerebral palsy is a permanent damage in early brain in fetus which leads to movement disorder. The most frequent reason of bodily incapacity is cerebral palsy in pediatric population. CP children have difficulty maintaining dynamic and static trunk stability, which leads to affect sitting, standing, reaching and walking. Hemiplegic Cerebral palsy patients are challenged by fine motor skills, like gripping or object handling, which are essential for activities of daily life.the purpose of the study was to evaluate the effects of trunk stability exercises on hand function in children with cerebral palsy.It was a randomized, controlled trial, conducted among hemiplegic cerebral palsy patients. Sample size was 26 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on three occasions: (i) baseline (ii) post-intervention and (iii) after 4 weeks follow to assess long term effects.
- Conditions
- Cerebral Palsy
- Being tested
- conservative physiotherapy plan, trunk stability exercise plan
- Keywords
- trunk stability, hand function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative physiotherapy planOther
Physiotherapy plan consist of following exercises, Postural and Proprioceptive facilitation like weight-bearing actions for the upper and lower extremities. Sit to stand, standing , holding on to stand, free arms standing up, holding on standing and asked the patient to lift one leg, one leg standing, standing on balance board,Straight and sideways parallel bar walk, For the effected body side jumping on stable and dynamic surface,Upstairs and down stair activity performed on staircase.This program was given for 40 minutes with a rest period of 2 minutes between each group of exercises, 4 days a week for 8 weeks (32 sessions)
trunk stability exercise planOther
trunk stability exercise plan consist of three levels, Proprioception included supine abdominal draw was performed in 1st simple level ,3 sets per 20 repetitions were performed, A double knee to chest abdominal draw was performed with 3 sets per 20 repetition, Supine twist with 3 sets per 20 repetitions was performed.Balance training included pelvic bridging was 2nd complicated level performed with 3 sets per 4-6 repetitions,Twists with a medicine ball were performed with 3 sets per 10-20 repetitions.
for Stability Bridging with head lied on physio ball was performed in 3rd difficult level when holding the position for 4 to 6 seconds, then relaxed slowly for same time with 3 sets per 10 to 20 repetitions, Prone bridging was performed with 3 sets per 4 to 6 repetitions.
There was a 30 seconds to 1 minute break between the sets.This program was given for 1 hour with a rest period of 2 minutes between each group of exercises, 4 days a week for 8 weeks (32 sessions)
| Study group | Role | What they receive |
|---|---|---|
| conservative physiotherapy plan | Active comparator | Postural and Proprioceptive facilitation,walking ,jumping and staircase activity Receives: Other: conservative physiotherapy plan; Other: trunk stability exercise plan |
| Trunk stability exercise plan | Experimental | Trunk stability exercises including proprioception,balance and stability. Receives: Other: conservative physiotherapy plan; Other: trunk stability exercise plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Meaurment Scale
The trunk control measurement scale measures two mechanism of trunk control throughout functional activities. First level begins with smooth base of support and it ends on dynamic service to assess balance of body.15 items performed with the sub scales that consist of 5, 7 and 3 activities respectively. Total score ranges from 0 to 58 on scale.
Measured: 12 week
ABILHAND-kids (Manual Ability Measure)
ABILHAND-Kids questionnaire is valuable tool to assess a child's unimanual and bimanual upper limb activities. This 21 items hand use scale with total 63 score prestents low to high performance of fine motor .
Measured: 12 week
CHEQ (Children's hand-use experience's questionnaire)
Children's Hand-use Experience Questionnaire has been developed to capture kid's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet based questionnaire containing 29 items with (bimanual activities) presented one by one in random order .score ranges from 0 to 100 representing better function with higher score .
Measured: 12 weeks
Secondary outcomes (3)
UE MAL
It consists of both the AS and HW scales are used during all test administrations, except for the periodic administrations of MAL during treatment, when only the HW scale is used. In all administrations except those done during treatment, begin with AS scale and ask participants to rate all task using the AS scale first the participant than rates all tasks perform with the HW scale
Measured: 12 weeks
Manual ability classification system
It's a 5 level ordinal classification system which describes the manual ability of children aged 4 to 18 years with cerebral palsy. When children holds objects in typical activities, MACS levels describe the collaborative use of both hands together in daily life activities .As a classification system the purpose of MACS is to discriminate meaningfully on child's manual ability to handle objects in daily living. It's not an outcome measure or diagnostic tool
Measured: 12 weeks
Modified ash worth scale (MAS)
The original ash worth scale by Bryan Ashworth was a five point numerical scale that graded spasticity from 0 to 4, with zero being no resistance and 4 being a limb rigid in flexion or extension. In 1987 when while performing a study to exam reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the ash worth scale by adding 1+ to scale to increase sensitivity. Since modified ash worth scale has been applied in clinical practice and research as measure/grade muscle spasticity
Measured: 12 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 start28 Oct 2021
- Primary completion25 Feb 2022
- Study completion25 May 2022
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.
- 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
- . Participants were randomly assigned to the experimental group or control group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled "control" or "intervention." Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Shafique, tDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491863
- Sponsor's protocol ID
- REC/RCR & AHS/22/0710
- Status last verified
- Aug 2022
- First submitted
- 24 Jul 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05491863
- Acronym / sponsor ID
- REC/RCR & AHS/22/0710
- Conditions
- Cerebral Palsy
- Keywords
- trunk stability, hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 May 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.
Rationale of this research is to evaluate the outcome of trunk stabilizing exercises on the fine motor skills of subjects with hemiplegic CP. The significance of this study is to identify how much core stability exercises improve hand function. This study will help gather evidence on the practice of core stabilizing exercises to improve hand function so that it can help both physicians and patients.
Detailed description
Cerebral palsy is a permanent damage in early brain in fetus which leads to movement disorder. The most frequent reason of bodily incapacity is cerebral palsy in pediatric population. CP children have difficulty maintaining dynamic and static trunk stability, which leads to affect sitting, standing, reaching and walking. Hemiplegic Cerebral palsy patients are challenged by fine motor skills, like gripping or object handling, which are essential for activities of daily life.the purpose of the study was to evaluate the effects of trunk stability exercises on hand function in children with cerebral palsy.It was a randomized, controlled trial, conducted among hemiplegic cerebral palsy patients. Sample size was 26 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on three occasions: (i) baseline (ii) post-intervention and (iii) after 4 weeks follow to assess long term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- . Participants were randomly assigned to the experimental group or control group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled "control" or "intervention." Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to
| Arm | Type | Receives |
|---|---|---|
| conservative physiotherapy plan | Active comparator | Other: conservative physiotherapy plan, Other: trunk stability exercise planPostural and Proprioceptive facilitation,walking ,jumping and staircase activity |
| Trunk stability exercise plan | Experimental | Other: conservative physiotherapy plan, Other: trunk stability exercise planTrunk stability exercises including proprioception,balance and stability. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Both male and female were included
- Age group 6 to 18 years.
- Medical diagnosis of hemiplegic cerebral palsy assured.
- Unilateral Movement deficit (less than 2.5) on amount of use scale on MAL (motor activity log).
- Level 1 to 3 on manual ability classification system (MACS).
Key exclusion criteria (6 listed)
- Patients with altered conscious level.
- Previous surgery or pain in upper limbs.
- Rigid contracture and fixed deformities in the spine
- Auditory / vision problem.
- Previous Botulinum Toxin-A injections in upper limb.
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 |
|---|---|---|
| conservative physiotherapy planPhysiotherapy plan consist of following exercises, Postural and Proprioceptive facilitation like weight-bearing actions for the upper and lower extremities. Sit to stand, standing , holding on to stand, free arms standing up, holding on standing and asked the patient to lift one leg, one leg standing, standing on balance board,Straight and sideways parallel bar walk, For the effected body side jumping on stable and dynamic surface,Upstairs and down stair activity performed on staircase.This program was given for 40 minutes with a rest period of 2 minutes between each group of exercises, 4 days a week for 8 weeks (32 sessions) | Other | Trunk stability exercise plan, conservative physiotherapy plan |
| trunk stability exercise plantrunk stability exercise plan consist of three levels, Proprioception included supine abdominal draw was performed in 1st simple level ,3 sets per 20 repetitions were performed, A double knee to chest abdominal draw was performed with 3 sets per 20 repetition, Supine twist with 3 sets per 20 repetitions was performed.Balance training included pelvic bridging was 2nd complicated level performed with 3 sets per 4-6 repetitions,Twists with a medicine ball were performed with 3 sets per 10-20 repetitions. for Stability Bridging with head lied on physio ball was performed in 3rd difficult level when holding the position for 4 to 6 seconds, then relaxed slowly for same time with 3 sets per 10 to 20 repetitions, Prone bridging was performed with 3 sets per 4 to 6 repetitions. There was a 30 seconds to 1 minute break between the sets.This program was given for 1 hour with a rest period of 2 minutes between each group of exercises, 4 days a week for 8 weeks (32 sessions) | Other | Trunk stability exercise plan, conservative physiotherapy plan |
Primary outcome
Trunk Control Meaurment Scale
Time frame: 12 week
The trunk control measurement scale measures two mechanism of trunk control throughout functional activities. First level begins with smooth base of support and it ends on dynamic service to assess balance of body.15 items performed with the sub scales that consist of 5, 7 and 3 activities respectively. Total score ranges from 0 to 58 on scale.
ABILHAND-kids (Manual Ability Measure)
Time frame: 12 week
ABILHAND-Kids questionnaire is valuable tool to assess a child's unimanual and bimanual upper limb activities. This 21 items hand use scale with total 63 score prestents low to high performance of fine motor .
CHEQ (Children's hand-use experience's questionnaire)
Time frame: 12 weeks
Children's Hand-use Experience Questionnaire has been developed to capture kid's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet based questionnaire containing 29 items with (bimanual activities) presented one by one in random order .score ranges from 0 to 100 representing better function with higher score .
3 secondary outcomes
UE MAL
Time frame: 12 weeks
Manual ability classification system
Time frame: 12 weeks
Modified ash worth scale (MAS)
Time frame: 12 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.
- 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 Shafique, tDPT 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 conservative physiotherapy plan and trunk stability exercise plan in people with 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 8 inclusion and 6 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?
Trunk Control Meaurment Scale (time frame: 12 week). 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 8 Aug 2022.