Effects of Dynamic Surface Exercise Training in Children With Diplegic Cerebral Palsy

NCT ID: NCT07244159

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2026-01-30

Brief Summary

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Data will be collected after the approval of synopsis a total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.

Detailed Description

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This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times).

This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set. On floor, standing: throwing and catching the ball from different direction, 10 times each side, 1 set Gross motor function measure-88 and pediatric balance scale and time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention

Conditions

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Child, Only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized clinical trial,total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will get separate treatment protocols efforts will be put to mask the both groups about the treatment

Study Groups

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Group A

This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions)

Group Type ACTIVE_COMPARATOR

Dynamic surface exercise training

Intervention Type OTHER

This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times.

Group B

This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day. On bench, patient forward bend and pick the ball, come back to sitting and through the ball for 10 times and 1 set

Group Type ACTIVE_COMPARATOR

Standard physiotherapy Training

Intervention Type OTHER

This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day.

Interventions

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Dynamic surface exercise training

This group will be given dynamic surface exercise training lasting for 60 minutes, 4 days /week for 6 weeks. For balance, the first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10e20 repetitions), and supine twist (10e20 repetitions) . The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3e5 s, followed by a slow relaxation phase, with 10e20 repetitions) and prone bridging (the entire sequence was repeated 3e5 times.

Intervention Type OTHER

Standard physiotherapy Training

This group will be given standard physiotherapy training lasting for 60 minute, 4 days/week for 6 weeks. Standard physiotherapy includes side sitting on bench/stool to quadruped-quadruped to side sit (transition activity) 5 times each side and 1 set in a day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 5 and 8 years of both genders
* Classification as level III and IV on the Gross Motor Function Classification system (GMFCS)

Exclusion Criteria

* • Any orthopedic surgery or botulinum toxin injection in the past 6 months.

* Refusal by the parents to participate.
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafiza Iram Batool, MS-PT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Hafiza Iram Batool

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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IMRAN AMJAD, Phd

Role: CONTACT

9233224390125

Muhammad Asif Javed, MS-PT

Role: CONTACT

923224209422

Facility Contacts

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Muhammad Asif Javed, MS-PT

Role: primary

923224209422

References

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Salphale VG, Kovela RK, Qureshi MI, Harjpal P. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on Balance and Gait Parameters in Children With Spastic Diplegia. Cureus. 2022 Oct 22;14(10):e30571. doi: 10.7759/cureus.30571. eCollection 2022 Oct.

Reference Type BACKGROUND
PMID: 36415346 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/HAFIZA IRAM BATOOL

Identifier Type: -

Identifier Source: org_study_id

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