Isokinetic Strength Training in Children With Hemiparetic Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Optimization of Weight-bearing- and Walking-symmetry and Dynamic Balance Using an Isokinetic Strength Training Protocol in Children With Hemiparetic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907448
• Other study ID #: RHPT/0018/0062
• Status: Completed
• Phase: N/A
• Start date: December 23, 2018
• Est. completion date: January 9, 2020

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Thirty-six children with HCP were recruited from the Physical Therapy Outpatient Clinic of Collee of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, King Khalid Hospital, and a tertiary referral hospital, Al-Kharj, Saudi Arabia. Their age ranged between 8 and 16 years, were functioning at levels I or II according to the Gross Motor Function Classification System, and had spasticity level 1 or 1+ per the Modified Ashworth Scale. Children were excluded if they had structural nonreducible deformities, underwent neuromuscular or orthopedic surgery in the last 12 months, submitted to BOTOX injection in the past 6 months, sensory-perceptual disorders, unstable convulsions, cardiopulmonary problems preventing them from performing high-intense exercise training.

Outcome measures

1. Weight-bearing symmetry index: The weight-bearing symmetry index for the rearfoot and forefoot segments were assessed through a pressure analysis system

2. Gait-symmetry Indices: Gait symmetry indices (Spatial and temporal) were measured through the portable GAIT Rite system.

3. Dynamic balance: The directional dynamic limit of stability (forward, backward, paretic, and non-paretic) and overall limit of stability were assessed using the Biodex balance system.

The IsoK-ST and control groups received their usual physical rehabilitation program for 45 minutes, three times a week for eight consecutive weeks. The program comprised advanced balance training, and gait training exercises, postural and flexibility exercises, strength training exercises. Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight weeks per the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The IsoK-ST consisted of 3 sets (5-10 repetitions) of maximal concentric contraction of knee extensors and flexors on the affected side at angular speeds of 90, 120, 180, and 240 deg./sec., with intervals of rest for two minutes after each selected speed. The IsoK-ST workout was proceeded by a 5-minute warm-up and ended up with a 5-minute cool-dowm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Physical Therapy
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.

Locations

Country	Name	City	State
Saudi Arabia	Ragab K. Elnaggar	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-bearing symmetry	The weight-bearing symmetry indices of the rearfoot and forefoot segments were measured using a Pressure analysis system.	2 months
Primary	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
Primary	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