Clinical trial NCT05106829: Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children
Official title: Effect of Treadmill Training Combined With Ankle Weights on Balance in Spastic Cerebral Palsied Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Treadmill
Biodex Balance System
Cerebral Palsy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Physical therapy and ankle weights.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Balance
timeFrame: Up to 8 weeks
measure: Muscle strength
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Functional balance assessment
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
Study officials:
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