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Completed

NCT Number: NCT05348135

Combined Cognitive and Functional Strength Training in Children With cp

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

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Key information

Conditions

Diplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Of Physical Therapy

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

functional strength training

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

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

Other

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

Primary outcomes

  1. change in GMFM-88 measures

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    criterion-referenced scale that measure gross motor function in children with CP.

  2. change in attention / concentration measures

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    • Computer based RehaCom software used to assess attention / concentration cognitive domain of function. It is clinically proven and evidence-based software.
    • minimum reaction time ( in seconds) of attention / concentration program was assessed

  3. change in figural memory measures

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    • Computer based RehaCom software used to assess figural memory cognitive domain of function.It is clinically proven and evidence-based software.
    • minimum reaction time ( in seconds) of figural memory program was assessed

  4. change in reaction behavior measures

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    Computer based RehaCom software used to assess reaction behavior cognitive domain of function. It is clinically proven and evidence-based software.

    • minimum reaction time ( in seconds) of reaction behavior program was assessed

  5. change in logical reasoning measures

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    Computer based RehaCom software used to assess logical reasoning cognitive domain of function. It is clinically proven and evidence-based software.

    • minimum reaction time ( in seconds) of logical reasoning program was assessed

Secondary outcomes

  1. change in Five times sit to stand test (FTSST) measure

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    measure the time spent for completing five sequential sit to stand to sit cycles. It is a reliable and valid measure of functional muscle strength and balance in CP children.

  2. change in Timed up and go test (TUG)measure

    Time frame: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

    A reliable and valid test used for assessing dynamic balance and functional mobility in the children.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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