Combined Cognitive and Functional Strength Training in Children With cp

NCT05348135 | Completed

• 1 other identifier: No:P.T.REC/012/003398
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (5)

• change in GMFM-88 measures

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

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

• change in attention / concentration measures

  * 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

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

• change in figural memory measures

  * 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

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

• change in reaction behavior measures

  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

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

• change in logical reasoning measures

  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

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

Secondary Outcomes (2)

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

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

• change in Timed up and go test (TUG)measure

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

Study Arms (4)

Functional strength training

ACTIVE COMPARATOR

Other: functional strength training

Cognitive training

ACTIVE COMPARATOR

Other: cognitive training

Combined treatment

ACTIVE COMPARATOR

Other: functional strength training; Other: cognitive training

Conventional physical therapy

PLACEBO COMPARATOR

Other: conventional physical therapy

Interventions

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.

Combined treatment; Functional strength training

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.

Cognitive training; Combined treatment

conventional physical therapy OTHER

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

Conventional physical therapy

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty Of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: April 27, 2022
• Study Start: October 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 11, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)