Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children

NCT05106829 | Unknown DMC

• 1 other identifier: P.T.REC/012/003112
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy

Keywords

Treadmill; Biodex Balance System; Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Balance

  Biodex Stability System will be used to measure overall stability index, anteroposterior stability index and mediolateral stability index.

  Up to 8 weeks

• Muscle strength

  Handheld dynamometer (Lafayette) will be used to record dorsiflexors force in pounds (Lbs)

  Up to 8 weeks

Secondary Outcomes (1)

• Functional balance assessment

  Up to 8 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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

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

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

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children ages will be ranged from 6 to 9 years old. 2-Confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist.
• 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.
• Independent standing and walking. 6-Ability to follow simple verbal commands and instructions

You may not qualify if:

• Auditory or visual defects or any perceptual defects.
• Fixed deformities on both upper or/ lower limbs.
• Botox injection.
• Cardiovasucular disease.
• Surgery within the previous 24 months.

Sponsors & Collaborators

• Beni-Suef University: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Eman Wagdy, PH.D

CONTACT

01008079576; Eman.wagdy@pt.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: By random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Physical therapy and ankle weights.

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: November 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 4, 2021

Record last verified: 2021-10