Effects of Functional Progressive Strength Training in Children With Spastic Cerebral Palsy

Not Applicable

Completed

• Conditions: Spastic Cerebral Palsy
• Interventions: Other: Functional Progressive Strength Training; Other: Control

• Registration Number: NCT06407869
• Lead Sponsor: Riphah International University

Brief Summary

This study focuses on the effects of Functional Progressive Strength Training (FPST) on children with spastic cerebral palsy, a condition characterized by increased muscle tone that affects movement. Spastic cerebral palsy is one type of cerebral palsy, with others including dyskinetic, which involves involuntary movements, and ataxic, which affects coordination. FPST differs from traditional strength training by incorporating exercises that replicate everyday activities to integrate strength use in daily movements. The study uses an experimental design with participants aged 6-12 years, recruited from specialized centers. They are randomly assigned to either a treatment group receiving FPST or a control group receiving standard care. The study aims to measure improvements in gait and mobility, assessed through various tools like step and stride length, cadence, and gait speed, alongside caregiver reports and direct observations. Statistical analyses will determine the effectiveness of FPST in enhancing motor function and walking capacity in these children.

Detailed Description

In the outlined study, participants who fit the necessary inclusion and exclusion criteria are asked to provide written informed consent before taking part. The randomization process involves each participant drawing a number from a box: those who draw number one are placed in Group A (experimental group), while those drawing number two are placed in Group B (control group).

Group A undergoes a specialized treatment approach called Functional Progressive Resistance Exercise (FPRE), in addition to receiving conventional treatment. The FPRE regimen starts with a three-minute warm-up that includes range of motion mobilization and stretching exercises. This is followed by a series of resistance exercises, such as sit-to-stand activities, which increase in intensity over a six-week period, targeting specific percentages of body weight. The participants then engage in half-kneeling, standing up, and side-step-up exercises for 20 minutes each, with rest intervals. The session concludes with a two-minute cooldown. The protocol is designed to gradually increase the load carried by the participants, scaling up to five times, then 10 times, and eventually 15 times the initial weight, with a minimum of one minute of rest between sets. The exercises are calibrated through trial and error to find the maximum load that can be lifted for the defined number of repetitions and sets.

Group B participants receive conventional physical therapy aimed at maintaining muscle flexibility and improving motor function. Their routine includes an hour-long session three times a week, consisting of stretching exercises focused on muscles prone to tightness, such as the Achilles tendons, hamstrings, hip flexors, and adductors. Strength training targets specific muscle groups including hip flexors, knee extensors, and ankle dorsiflexors. The gait training in Group B starts in a controlled environment, such as walking between parallel bars, and progresses to more complex tasks like walking unassisted in open spaces, navigating different floor surfaces, and moving through obstacle-laden paths.

Both groups are reassessed after 12 weeks to evaluate the impact of their respective interventions on gait parameters and walking capacity, using a combination of direct observation, caregiver reports, and standardized assessment tools. The study aims to ascertain the relative efficacy of these two approaches in enhancing mobility and quality of life for children with spastic cerebral palsy.

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Study Start: 2024-06-28
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged 6 to 12 years
• Children had to be able to understand and follow instructions
• Diplegic CP
• GMFSC I, II, III

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Exclusion Criteria

• Treatment with botulinum toxin A in lower limb.
• Rhizotomy done 6 months before the study.
• Children with unstable seizures will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional Progressive Strength Training	Functional Progressive Strength Training	group of 20 children with spastic cerebral palsy on which FPST techniques including 3 or 4 PRT sessions per week for 12 weekswill be applied.
Control	Control	group of 20 children with spastic cerebral palsy on which conventional physical therapy techniques will be applied

Primary Outcome Measures

Name	Time	Method
Gait Parameters	12 weeks	To assess gait parameters in a study, four tools are utilized: step length, measuring the distance between alternating heel strikes; stride length, measuring the distance between two heel strikes of the same extremity; cadence, counting the number of steps taken; and gait speed, timing the duration to cover a 5-meter distance with a stopwatch.

Secondary Outcome Measures

Name	Time	Method
1-Minute Walk Test	12 weeks	The 1-minute walk test assesses walking capacity on a 20-meter indoor track, recording the distance a participant covers in one minute while walking as fast as possible without running.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Lahore, Punjab, Pakistan