| CTRI Number |
CTRI/2025/01/079502 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hand function in hemiplegic cerebral palsy |
|
Scientific Title of Study
|
Effect Of core stability exercises with Pilates on hand functioning in hemiplegic cerebral palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirtika Bhandari |
| Designation |
PG Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar, Uttar Pradesh, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7456071877 |
| Fax |
|
| Email |
kirtika.bhandari@s.amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar, Uttar Pradesh, 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9810280418 |
| Fax |
|
| Email |
ngupta4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Gupta |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar, Uttar Pradesh, 201301
UTTAR PRADESH
201301
India |
| Phone |
9810280418 |
| Fax |
|
| Email |
ngupta4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Reborn Physiotherapy And Neuro Rehabilitation clinic, Plot No 649 Ground Floor, near Maansarovar Bhawan, Shakti Khand 4, Indirapuram, Ghaziabad, Uttar Pradesh, 201014 |
|
|
Primary Sponsor
|
| Name |
Kirtika Bhandari |
| Address |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kirtika Bhandari |
Reborn Physiotherapy And Neuro Rehab Center |
Plot No. 649 Ground Floor, near Maansarovar Bhawan, Shakti Khand-4, Indirapuram, Ghaziabad, Uttar Pradesh 201014
Ghaziabad
UTTAR PRADESH |
7456071877
kirtika.bhandari@s.amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Istitutional NTCC Committee Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
| Reborn Physiotherapy and Neuro Rehab Clinic |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core stability exercise with Pilates and some exercise from comparative group physiotherapy treatment. |
The intervention group will receive Pilates-based core stability exercises and stretching, weight bearing, strengthening exercises, divided into two levels. These exercises will take 1 hour, with two minutes of recovery in between each set. For 8 weeks, these workouts will be performed five times a week. Stretching for 5 minutes. Exercises includes mat exercises with include Pilates (positioning on mat with and without support 5 minutes each, quadruped position 3 minutes, curls up 3 minutes), on floor (standing exercise 10 minutes, step up and down 10 repetition), Swiss ball exercise 2 minutes, balance board activities 5 minutes, hand function activities 10 minutes. |
| Comparator Agent |
core stability exercises and selected (stretching, weight bearing, strengthening exercises) physiotherapy treatment. |
The comparative group will receive stretching, weight bearing, strengthening exercises and core stability exercises, divided into two levels. These exercises will take an hour, with two minutes of recovery in between each set. Stretching for 5 minutes. Mat exercises (positioning on mat with and without support 10 minutes, spine twisting 10 repetition), on floor (standing exercise 10 minutes), Swiss ball exercise 5 minutes, balance board activities 5 minutes, hand function activities 15 minutes. |
|
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. diagnosed by a paediatric neurologist with hemiplegic cerebral palsy
2. impairment of the upper limbs (Jebsen Taylor Hand Function Test score greater than 140 seconds)
3. moderate upper limb spasticity (Grades 1 and 1+ on the Modified Ashworth Scale)
4.Levels II and III of the Gross Motor Function Classification System
5. Patient have the ability to take command.
|
|
| ExclusionCriteria |
| Details |
1. Individuals who have fixed contractures in their extremities or spine
2. Any spasticity-related medicinal or surgical interventions
3. Refused to take part
4. Any illness other than cerebral palsy that affects hand function, including neurological, cardiac, psychiatric, and orthopaedic conditions.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Jebsen Taylor Hand Function Test |
Baseline, Post 4th week intervention, Post 8th week intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Upper Extremity Skills Test |
Baseline, Post 4th week intervention, Post 8th week intervention |
|
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Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Need of the study- - Core stability exercises play key role in limb function. Hemiplegic Cerebral Palsy children are unable to move the upper limb of the involved side due to an unstable spine. We can strain the core muscles which will make hand activities easier keeping the trunk stable. Aims- The aim is to study the effect of core stability with Pilates in hemiplegic cerebral palsy children.
Objectives: The objective is to study the effect of core stability exercises with Pilates on hand function as measuring by Jebsen Hand Functioning Test in hemiplegic cerebral palsy children. The objective is to study the effect of core stability exercises with Pilates on hand function as measuring by Quality of Upper Extremity Skill Test. Hypothesis- Alternative hypothesis- core stability exercise with Pilates will help in improving hand function. Null hypothesis- core stability exercise with Pilates will ‘not’ help in improving hand function. Group Allocation: a) Comparative group: selective exercises and core stability exercises b) Intervention group: core stability exercise with Pilates and some exercise from comparative physiotherapy treatment. Procedure: Every participant will have standard upper and lower extremity physiotherapy exercises that will help with postural mechanisms, proprioception feeling, and weight-bearing exercises as well as strengthening exercises for the back, hip, knee, ankle, and abdomen. Exercises involving standing and gait training at varying speeds with and without support will be performed. These workouts will take an hour, with two minutes of recovery in between each set. For 8 weeks, these workouts will be performed five times a week. The comparative group I will receive selected exercise and core stability exercise: LEVEL 1 (4 Weeks) Five times a week for four weeks, stretching for five minutes, exercise for fifty-five minutes, and rest for two minutes in between each group. On mat | Kneeling while being supported by hands | 5 minutes | |
Kneeling on one leg while holding on with hands
| 5 minutes | |
Twist of the spine
| 10 repetitions in 2 minutes | On floor | Holding on when standing | 5 minutes | | Standing on a stepper with one leg | 5 minutes | 0n ball | Maintain sitting position | 5 minutes | On balance board | Using hand support while standing on a balancing board | 5 minutes | HAND FUNCTION EXERCISE- 15 minutes · Fruit lacing bead activity · Fitting blocks together · Hold a cup with one hand while putting object in with other hand · Catching a ball Level 2 (4 Weeks) On mat | moderate assistance kneeling | 5 minutes | | Kneeling on one leg with moderate assistance | 5 minutes | | Supine bridge with support | 10 repetitions in 4 minutes | On floor | Standing with a moderate amount of assistance | 5 minutes | | step up and down. | 5 minutes | On ball | Twisting of the trunk while seated | 2 minutes | | Cobra pose | 2 minutes | On balance board | Weight shift in the anterior, posterior, and lateral directions | 4 minutes | HAND FUNCTION EXERCISE- 15 minutes · Fruit lacing bead activity · Fitting blocks together · Geometrical shape for grasping · Catching a ball
Pilates-based core stability exercises and few comparative group exercises will be given to the intervention group II. These workouts will take an hour, with two minutes of recovery in between each set. For 8 weeks, these workouts will be performed five times a week.
LEVEL 1 (4 weeks) On mat | Kneeling while being supported by hands | 5 minutes | | Kneeling on one leg while holding on with hands | 5 minutes | | Quadruped position | 3 minutes | | Curl up | 3 minutes | On floor | Holding on when standing | 5 minutes | | Standing on a stepper with one leg on and other leg on ground | 5 minutes | | Stepping up and down | 10 repetitions 4 minutes | On balance board | Weight shifting from side to side and forward and backward | 5 minutes | On ball | Weight shift from sitting in the anterior and posterior | 1 minutes | | shift in weight laterally from sitting | 1 minutes |
HAND FUNCTION EXERCISE- 10 minutes
· fruit lacing bead activity · Fitting blocks together · Hold a cup with one hand while putting object in with other hand · Catching a ball LEVEL 2 (4 weeks) On Mat | Curl up | 2 set 10 repetition 4 minutes | | Ladder climb | 3 minutes | | One knee float | 10 repetitions 2 minutes | | Move from a prone-lying position to a quadruped one. | 5 minutes | On floor | Walking like a wheelbarrow | 5 minutes | | Asking the patient to raise one leg while standing and hanging on | 5 minutes | On Balance board | Reaching both forward and obliquely | 6 minutes | | Flamingo exercise | 4 minutes | On Ball | lateral, anterior, and posterior weight shift | 5 minutes | | Rotating the trunk from side to side when lying supine
| 5 minutes | HAND FUNCTION EXERCISE- 15 minutes · fruit lacing bead activity · Fitting blocks together · Geometrical shape for grasping · Catching a ball
|