Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children

NCT ID: NCT05106829

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-01-01

Brief Summary

The purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.

Detailed Description

Cerebral palsy defined as a non-progressive, non-hereditary lesion of the cerebral cortex resulting in postural and motion disturbances. Spastic cerebral palsied children have deficits in the selection of appropriate sensory inputs for postural control. Balance is a complex motor skill often referred to as postural control which is the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over the base of support. Treadmill gait training supporting the body weight which simulates walking on flat land is prescribed in rehabilitation of spastic cerebral palsy to improve their balance or to reduce their gait disturbance. Several studies support the use of ankle weights during treadmill gait training to reinforce muscle strength and, improve the symmetry of gait while, there is no research conducted on balance in spastic cerebral palsied children. Hence, there is need to study the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.

Fourty children with spastic hemiparetic cerebral palsied children (based on power analysis) from both sexes (6-9 years) will be recruited from different private pediatric physical therapy clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in designed physical therapy program in addition to gait training on treadmill with full weight bearing without using of ankle weights. Study group will be participated in the same designed physical therapy program received by the control group in addition to gait training on treadmill with ankle weights on the affected side ankle.

Conditions

Cerebral Palsy

Keywords

Treadmill; Biodex Balance System; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical therapy program with treadmill training without using of ankle weights.

Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill for 30 min./ session.

Group Type: ACTIVE_COMPARATOR

Physical therapy program with treadmill training without using of ankle weights.

Intervention Type: OTHER

The physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill without ankle weights.

Physical therapy program with treadmill training with using of ankle weights.

Cerebral palsied children will receive the physical therapy program from 45- 60 min./ session in addition to gait training on treadmill with ankle weights for 30 min./ session.

Group Type: EXPERIMENTAL

Physical therapy program with treadmill training with using of ankle weights.

Intervention Type: OTHER

he physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill with ankle weights.

Interventions

Physical therapy program with treadmill training without using of ankle weights.

The physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill without ankle weights.

Intervention Type: OTHER

Physical therapy program with treadmill training with using of ankle weights.

he physical therapy program include manual standing on the mat, manual standing on the mat with step forward and step backward, kneeling and half kneeling on the mat, changing position exercises from prone to standing and from supine to standing, equilibrium, protective and righting reactions using balance board and medical ball, balance training exercise from standing on the mat, strengthening exercises for weak dorsiflexors, stooping and recovery exercising from standing position, squatting to standing exercise, gait training in different directions and, stretching exercises for tight muscles (e.g: hip flexors, hamstrings and calf muscles in lower limb and for wrist flexors, pronators and elbow flexors in upper limb) + gait training on treadmill with ankle weights.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1-Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist.

3-Spasticity grades ranged from 1 to +1 according to modified Ashworth. 4-Balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the Biodex stability system.

5-Independent standing and walking. 6-Ability to follow simple verbal commands and instructions

Exclusion Criteria

1. Auditory or visual defects or any perceptual defects.

2. Fixed deformities on both upper or/ lower limbs.

3. Botox injection.

4. Cardiovasucular disease.

5. Surgery within the previous 24 months.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Eman Wagdy

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eman Wagdy, PH.D

Role: CONTACT

Phone: 01008079576

Email: Eman.wagdy@pt.bsu.edu.eg

Other Identifiers

P.T.REC/012/003112

Identifier Type: -

Identifier Source: org_study_id