Isokinetic Strength Training in Children With Hemiparetic Cerebral Palsy

NCT04907448 | Completed

• 1 other identifier: RHPT/0018/0062
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study endeavored to assess the effect of an isokinetic strength training (IsoK-ST) program on weight-bearing symmetry, gait-symmetry, and dynamic balance in children with hemiparetic cerebral palsy (HCP). Thirty-six children with HCP were randomly allocated to the IsoK-ST group (n = 18, received their usual physical rehabilitation program plus an IsoK-ST program) or the Control group (n =18, received usual physical rehabilitation alone). Both groups were assessed for weight-bearing symmetry, gait-symmetry, and dynamic balance before and after treatment.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Weight-bearing symmetry

  The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.

  2 months

• Gait-symmetry indices

  Gait symmetry indices (spatial and temporal) were measured about the step length and single-limb support time of the paretic and non-paretic leg through the portable GAIT Rite system

  2 months

• Dynamic balance

  The directional (forward, backward, paretic, and non-paretic) and overall dynamic limits of stability were assessed through the Biodex balance system.

  2 months

Study Arms (2)

IsoK-ST group

EXPERIMENTAL

Participants in this group received the usual physical rehabilitation program in addition to an IsoK-ST program.

Other: Physical Therapy

Control group

ACTIVE COMPARATOR

Participants in this group received the usual physical rehabilitation program only.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

The IsoK-ST group received their usual physical therapy program for 45 minutes, three times a week for eight successive weeks, which comprised advanced balance training, weight-bearing exercises, gait training, postural and flexibility exercises, and strength training exercises. Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight successive weeks. The control group received the usual physical rehabilitation program only for 45 minutes, three times a week for eight successive weeks.

Control group; IsoK-ST group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hemiparetic cerebral palsy
• Age 8-16 years
• Motor function level I or II according to the Gross Motor Function Classification System.
• Spasticity level 1 or 1+ according to the Modified Ashworth Scale

You may not qualify if:

• Structural deformities
• Musculoskeletal or neural surgery in the last year
• BOTOX injection in the last 6 months.
• Cardiopulmonary disorders interfering with the ability to engage in exercise training.
• Hemispatial neglect.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective pre-test post-test randomized controlled trial

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: December 23, 2018
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)