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Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children

B

Beni-Suef University

Status

Unknown

Conditions

Cerebral Palsy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05106829
P.T.REC/012/003112

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 9 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Physical therapy program with treadmill training without using of ankle weights.
Active Comparator group
Description:
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.
Treatment:
Other: Physical therapy program with treadmill training without using of ankle weights.
Physical therapy program with treadmill training with using of ankle weights.
Experimental group
Description:
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.
Treatment:
Other: Physical therapy program with treadmill training with using of ankle weights.

Trial contacts and locations

0

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Central trial contact

Eman Wagdy, PH.D

Data sourced from clinicaltrials.gov

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