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

NCT ID: NCT06407869

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2024-08-25

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.

Conditions

Spastic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional Progressive Strength Training

Intervention Type: OTHER

The Functional Progressive Resistance Exercise (FPRE) protocol is designed to improve functional strength through structured workouts. It begins with a 3-minute warmup involving stretching and range of motion exercises, followed by progressively intense sit-to-stand exercises over six weeks. Participants also perform half-kneeling, standing up, and side-step-up exercises, with 20 minutes of total activity and rest intervals. The session ends with a 2-minute cooldown. Weights are gradually increased up to 15 times the initial load, with a minimum of one-minute rest between sets. The regimen is tailored through trial and error to find the maximum load participants can effectively manage.

Control

group of 20 children with spastic cerebral palsy on which conventional physical therapy techniques will be applied

Group Type: OTHER

Control

Intervention Type: OTHER

conventional physical therapy techniques will be applied

Interventions

Functional Progressive Strength Training

The Functional Progressive Resistance Exercise (FPRE) protocol is designed to improve functional strength through structured workouts. It begins with a 3-minute warmup involving stretching and range of motion exercises, followed by progressively intense sit-to-stand exercises over six weeks. Participants also perform half-kneeling, standing up, and side-step-up exercises, with 20 minutes of total activity and rest intervals. The session ends with a 2-minute cooldown. Weights are gradually increased up to 15 times the initial load, with a minimum of one-minute rest between sets. The regimen is tailored through trial and error to find the maximum load participants can effectively manage.

Intervention Type: OTHER

Control

conventional physical therapy techniques will be applied

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kashaf Naeem, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Hanssen B, Peeters N, De Beukelaer N, Vannerom A, Peeters L, Molenaers G, Van Campenhout A, Deschepper E, Van den Broeck C, Desloovere K. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology. Front Physiol. 2022 Oct 4;13:911162. doi: 10.3389/fphys.2022.911162. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36267577 (View on PubMed)

Other Identifiers

REC/RCR&AHS/23/0778

Identifier Type: -

Identifier Source: org_study_id