Combined Cognitive and Functional Strength Training in Children With cp

NCT ID: NCT05348135

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-03-11

Brief Summary

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Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.

Detailed Description

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This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups

Conditions

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Diplegic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Functional strength training

Group Type ACTIVE_COMPARATOR

functional strength training

Intervention Type OTHER

children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.

Cognitive training

Group Type ACTIVE_COMPARATOR

cognitive training

Intervention Type OTHER

Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.

Combined treatment

Group Type ACTIVE_COMPARATOR

functional strength training

Intervention Type OTHER

children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.

cognitive training

Intervention Type OTHER

Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.

Conventional physical therapy

Group Type PLACEBO_COMPARATOR

conventional physical therapy

Intervention Type OTHER

including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training

Interventions

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functional strength training

children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.

Intervention Type OTHER

cognitive training

Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.

Intervention Type OTHER

conventional physical therapy

including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* chronological age ranged from 8 to 12 years,
* spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS
* can follow instructions given to them,
* their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II \& III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E\&R).

Exclusion Criteria

* children who had visual or auditory problems
* children who took any medicine affecting alertness
* fixed deformities in the joints of upper \& lower limbs
* any orthopedic surgery in lower limbs within 6 months before study
* epileptic children.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Fahmy Hassan Al Nemr

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty Of Physical Therapy

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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No:P.T.REC/012/003398

Identifier Type: -

Identifier Source: org_study_id

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