Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

NCT ID: NCT05321797

Last Updated: 2023-06-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-07-31

Brief Summary

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To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . The spastic CP is found to be the commonest presentation followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities .Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group A will be Control Group that will be provided with conventional physiotherapy (Stretching exercises , Trunk control training, walk and breathing exercises) and Group B will be Experimental Group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using spss 22.0.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Aerobic Training Group

Cycling exercise group along with Conventional therapy

Group Type EXPERIMENTAL

Aerobic Training

Intervention Type OTHER

This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period

Conventional Physiotherapy

Intervention Type OTHER

This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation

Conventional Physiotherapy

Strectching with ROM and gait training

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type OTHER

This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation

Interventions

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Aerobic Training

This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period

Intervention Type OTHER

Conventional Physiotherapy

This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 6-12 years of age both genders will be included.
* Ability to follow simple verbal instructions.
* Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system \[gmfcs\] levels i-iii)
* Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2

Exclusion Criteria

* Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
* Botulinum toxin injections within the preceding 3 months
* Serial casting or new orthotic devices within the preceding 3 months
* Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
* Inability or unwillingness to maintain age appropriate behavior
* Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
* Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 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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Fareeha Kausar, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Physiogic Physiotherapy Clinic

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Damiano DL, Stanley CJ, Ohlrich L, Alter KE. Task-Specific and Functional Effects of Speed-Focused Elliptical or Motor-Assisted Cycle Training in Children With Bilateral Cerebral Palsy: Randomized Clinical Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):736-745. doi: 10.1177/1545968317718631. Epub 2017 Jul 8.

Reference Type BACKGROUND
PMID: 28691601 (View on PubMed)

Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.

Reference Type BACKGROUND
PMID: 20093327 (View on PubMed)

Fujimoto J, Umemoto Y, Koike Y, Isida K, Sakamoto K, Tajima F. Immediate effects of short period lower limb ergometer exercise in adolescent and young adult patients with cerebral palsy and spastic diplegia. J Phys Ther Sci. 2021 Jan;33(1):52-56. doi: 10.1589/jpts.33.52. Epub 2021 Jan 5.

Reference Type BACKGROUND
PMID: 33519075 (View on PubMed)

da Rosa Pinheiro DR, Cabeleira MEP, da Campo LA, Correa PS, Blauth AHEG, Cechetti F. Effects of aerobic cycling training on mobility and functionality of acute stroke subjects: A randomized clinical trial. NeuroRehabilitation. 2021;48(1):39-47. doi: 10.3233/NRE-201585.

Reference Type BACKGROUND
PMID: 33386826 (View on PubMed)

El-Tamawy MS, Darwish MH, Basheer MA, Reda AM, Elzanaty M, Khalifa HA. Effect of cycling exercise on motor excitability and gait abnormalities in stroke patients. The Egyptian Journal of Neurology, Psychiatry and Neurosurgery. 2021;57(1):1-7

Reference Type BACKGROUND

Armstrong EL, Spencer S, Kentish MJ, Horan SA, Carty CP, Boyd RN. Efficacy of cycling interventions to improve function in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Clin Rehabil. 2019 Jul;33(7):1113-1129. doi: 10.1177/0269215519837582. Epub 2019 Apr 2.

Reference Type BACKGROUND
PMID: 30935240 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/21/0702

Identifier Type: -

Identifier Source: org_study_id

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