NCT04723641

Brief Summary

The functional strength training is mainly dealt with anti-gravity muscles and aiming at maximal carry over in day to day activities. The functional strength training can be given using resistance and it may be gravity, body weight, resistance bands and free weights. The exercises are specific to the muscle or muscle groups recruited during the functional activities

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

January 19, 2021

Last Update Submit

April 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gross motor functional measurement

    The GMFM is a standardized observational scale designed and validated to measure change in gross motor function over time in children with CP.

    pre and after 3 months of intervention,, the higer score will represent the improvement

Secondary Outcomes (1)

  • Isometric muscle strength measurements

    pre and after 3 months of intervention,, increase in muscle will represent the improvement

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

they received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.

Other: functional training exercises

control group

NO INTERVENTION

received a designed physical therapy program

Interventions

progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.

STUDY GROUP

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age ranged from 7 to 10 years old.
  • The degree of spasticity ranged from grade 1 to 2 hypertonia according to Modified Ashwarth Scale (MAS)
  • Level II and III on GMFCS-ER
  • They were able to understand and follow verbal instructions

You may not qualify if:

  • visual or auditory problems. 2- Orthopedic surgery in the lower limb in the last 12 months before the study. 3- Fixed deformities in joints and bones of lower limbs. 4- Botox injection in the last six months before the study. 5- Children with any special medications affecting muscle functions (anti-spastic drugs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: intervention group received progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer,department of physical therapy for pediatrics and pediatric surgery, badr university in cairo

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 26, 2021

Study Start

January 20, 2021

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations