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Status unknownNCT05106829Updated Nov 4, 2021

Treadmill With Ankle Weights on Balance in Spastic Cerebral Palsied Children

An interventional study of Physical therapy program with treadmill training without using of ankle weights. and Physical therapy program with treadmill training with using of ankle weights. in Cerebral Palsy, sponsored by Beni-Suef University. Status unknown. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • Treadmill
  • Biodex Balance System
  • Cerebral Palsy
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.

This study's planned enrollment of 40 is above the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    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.

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

  • Experimental
    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.

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

Interventions

  • OtherPhysical 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.

  • OtherPhysical 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.

06

What researchers measure

Primary outcomes

  1. Balance

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

    Time frame: Up to 8 weeks

  2. Muscle strength

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

    Time frame: Up to 8 weeks

Secondary outcomes

  1. Functional balance assessment

    Pediatric Balance Scale will be used to assess functional balance. It contains 14 items (Sitting to standing-Standing to sitting-Transfers-Standing unsupported-Sitting unsupported-Standing with eyes closed-Standing with feet together-Standing with one foot in front-Standing on one foot-Turning 360 degrees-Turning to look behind-Retrieving object from floor-Placing alternate foot on stool-Reaching forward with outstretched arm) that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

    Time frame: Up to 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05106829
Lead sponsor
Beni-Suef University
Responsible party
Eman Wagdy (lecturer, Beni-Suef University) — Principal investigator
First posted
Nov 4, 2021
Start date
Nov 1, 2021 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Nov 4, 2021

Study contacts

Eman Wagdy, PH.D
Contact
Eman.wagdy@pt.bsu.edu.eg
01008079576

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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