- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05491863
Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54792
- Rising Sun Institute for Special Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: conservative physiotherapy plan
Postural and Proprioceptive facilitation,walking ,jumping and staircase activity
|
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 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) |
|
Experimental: Trunk stability exercise plan
Trunk stability exercises including proprioception,balance and stability.
|
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 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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 week
|
|
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 .
|
12 week
|
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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 .
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UE MAL
Time Frame: 12 weeks
|
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
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12 weeks
|
|
Manual ability classification system
Time Frame: 12 weeks
|
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
|
12 weeks
|
|
Modified ash worth scale (MAS)
Time Frame: 12 weeks
|
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
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Shafique, tDPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0710
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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