NCT06966076

Brief Summary

Almost 2 to 3 out of every 1000 children have Cerebral palsy in Pakistan.Spastic type of CP is dominant about 75%, diplegia (40%) and hemiplegic are (35.5%).Spastic diplegics have tightness of lower limb more than upper limb.Their chief complaints are reduced mobility,impaired balance and coordination and lack of postural control and stability.Calisthenic training is sort of strengthening exercises in which patient use his/her own body weight as a resistance. Calisthenic training aims to reduce movement limitation,contracture formation and improves patient's mobility for daily transfers and ambulation,active participation of patient in indoor and outdoor activities and enhance postural stability and controle during routine tasks. The current study aims to determine the effects of calisthenic training on mobility and ADL performance in spastic diplegic cerebral palsy children aged 5-12 years fulfilling the GMFCS criteria levels 1-3. A randomized control trial will be conducted in multidisciplinary lab of FUCP, department of physical medicine and peads and rehabilitation of Fauji Foundation Hospital on the sample of 32 participants. The subjects will be randomized into two groups by sealed opaque envelope method. Baseline assessment would be done by using WEEFIM measurement assessment scale for mobility and ADL performance, pediatric balance assessment Scale for postural control. Data will be collected at baseline before intervention, after 3 weeks and finally after 6 weeks of intervention. Interventional group will be receiving calisthenic training and conventional physical therapy while control group will be receiving conventional physical therapy alone. Exercise training would be done for a total of 12 sessions for 6 weeks, twice a week with each session lasting 45 minutes. Analysis would be done by using SPSS version 21. Ethical approval will be obtained from ERC of FUSH. Informed written consent will be obtained from all participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 2, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

calisthenic trainingpostural controlconventional PTFES-Idynamic gait indexTUGberg balance scaleolder adultsrisk of fallfunctional mobilitybalancedual task trainingOtago exercise program

Outcome Measures

Primary Outcomes (2)

  • mobility

    The WeeFIM was used, it is an 18-item, 7-level ordinal scale. Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).

    8 weeks

  • Activities of Daily Living Performance

    Will be measured by weefim functional independence measure scale. It is an 18-item, 7-level ordinal scale. Each item is scored on a 7-level scale, with the total score ranging from 18 (lowest) to 126 (highest).

    8 weeks

Secondary Outcomes (1)

  • Postural control

    8 weeks

Study Arms (2)

calisthenic training group

EXPERIMENTAL

CALISTHENIC TRAINING CALISTHENIC EXERCISES COMMAND AND TARGET MUSCLE GROUP 1. LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND IN FRONT. LOWER THEM BACK DOWN WITHOUT TOUCHING THE FLOOR. TARGETS HIP FLEXOR 2. SIDE LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND AND TAKE IT TO SIDE MAXIMALL WITHOUT TOUCHING THE FLOOR. TARGETS LOWER ABS AND HIP ABDUCTORS 3. GLUTE BRIDGES ( BACK STRENGTH) LIE ON YOUR BACK WITH YOUR KNEES BENT. LIFT YOUR HIPS OFF THE GROUND, SQUEEZING YOUR GLUTES. LOWER AND REPEAT. TARGETS GLUTES AND HAMSTRINGS. 4. QUADRUPTED POSITION: ASK THE PATIENT TO RIDE YOUR KNEES PLAY 'HORSY' AND SLOWLY MOVE YOUR KNEES TO AND FRO AND SIDEWAYS SO THAT TO SHIFT WEIGHT FROM SIDE TO SIDE. 5. WALL LEG LIFTS 6. KNEELING 7. Vertical Lift 8. Squats

Procedure: calisthenic training

conventional physical therapy group

EXPERIMENTAL

CONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting

Procedure: Conventional physical therapy group

Interventions

COMMAND AND TARGET MUSCLE GROUP 1. LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND IN FRONT. LOWER THEM BACK DOWN WITHOUT TOUCHING THE FLOOR. TARGETS HIP FLEXOR 2. SIDE LEG RAISES (LEG STRENGTH) LIE ON YOUR BACK WITH YOUR LEGS STRAIGHT. LIFT LEGS OFF THE GROUND AND TAKE IT TO SIDE MAXIMALL WITHOUT TOUCHING THE FLOOR. TARGETS LOWER ABS AND HIP ABDUCTORS 3. GLUTE BRIDGES ( BACK STRENGTH) LIE ON YOUR BACK WITH YOUR KNEES BENT. LIFT YOUR HIPS OFF THE GROUND, SQUEEZING YOUR GLUTES. LOWER AND REPEAT. TARGETS GLUTES AND HAMSTRINGS. 4. QUADRUPTED POSITION: ASK THE PATIENT TO RIDE YOUR KNEES PLAY 'HORSY' AND SLOWLY MOVE YOUR KNEES TO AND FRO AND SIDEWAYS SO THAT TO SHIFT WEIGHT FROM SIDE TO SIDE. 5. WALL LEG LIFTS IN STANDING STAND WITH YOUR SIDE FACING A WALL. LIFT YOUR LEG OUT TO THE SIDE AS HIGH AS POSSIBLE. LOWER AND REPEAT WITH THE OTHER LEG. TARGETS HIP ABDUCTERS 6. KNEELING 7. VERTICLE LIFT 8. Squats

calisthenic training group

CONVENTIONAL PHYSICAL THERAPY CONVENTIONAL PHYSICAL THERAPY Week 1 Orientation of exercises Week 2-3 UPPER LIMB (20 MINS) Lifting a glass of water with elbow extended Moving objects from the table to a box Combing Hairs LOWER LIMB (20 MINS) Lifting the lower extremity and lowering in o nto a footstool sit to stand Standing up with loaded trey in hand corner hamstring stretch butterfly stretch Week 4-5 UPPER LIMB (20 MINS) Grasping and releasing objects lifting a glass of water to a level of 90° shoul der flexion with an extended elbow Moving objects from the table to a box LOWER LIMB (20 MINS) Reciprocal leg flexion and extension single leg stance Kicking a ball Week 5-8 UPPER LIMB (20 MINS) Opening Jars Throwing Balls Same As previous weeks LOWER LIMB (20 MINS) Squatting

conventional physical therapy group

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 5 and 13 years
  • Able to accept and follow verbal instructions
  • Able to participate in a training program
  • Based on Gross Motor Function Classification System (GMFCS SCALE 1,2 and 3)

You may not qualify if:

  • If they have controlled seizures
  • If they suffered from any inflammatory, infectious diseases, cognitive deficiencies and any musculoskeletal deformity with chronic contracture that interfere with physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

September 12, 2024

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations