Clinical trial NCT06434246: Effect of Pully System on Hemiplegic Children
Official title: Effect of Pully System Exercise on Upper Limb Function in Hemiplegic Cerebral Palsy Children: a Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction Cerebral palsy (CP) is a group of sensory, motor, and postural disorders caused by non-progressive brain injury in early development. It can manifest in various forms, including hemiplegia, which affects about 21% to 40% of CP cases. Upper extremity (UE) impairments in CP individuals are significant, impacting daily activities and quality of life.

Objective This study aims to investigate the effects of pulley system exercises on improving upper limb function in children with hemiplegic CP.

Methods Design: Randomized controlled double-blinded trial. Participants: 32 children aged 3-7 years with hemiplegic CP, divided into intervention and control groups.

Intervention: The intervention group receives pulley system exercises plus standard care, while the control group receives standard physical therapy.

Duration: Conducted between June 2024 and August 2024. Inclusion Criteria: Diagnosed with hemiplegic CP, aged 3-7 years, able to follow instructions, and with upper limb motor deficits.

Exclusion Criteria: Additional neurological disorders, recent upper limb surgery, previous rehabilitation programs, severe medical conditions, or contraindications to physical activity.

Assessment Tools: Assisting Hand Assessment (AHA), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Quality Upper Extremity Skills Test (QUEST), and Lafayette Manual Muscle Tester.

Timing: Baseline and after 3 months of intervention. Treatment Intervention Group: 45-60 minute sessions, three times a week, involving warm-up, pulley system exercises, and cool-down.

Control Group: Standard care physical therapy, twice a week, 45-60 minute sessions.

Statistical Analysis Methods: Descriptive statistics and Analysis of Covariance (ANCOVA) to analyze improvements in upper limb function.

Significance Level: p \< 0.05. Analysis: Intention-to-treat to handle missing data. This study aims to provide evidence on the effectiveness of pulley system exercises in enhancing upper limb function in children with hemiplegic CP, potentially improving their independence and quality of life.

Detailed description: Cerebral palsy (CP) is a collection of sensory and motor disorders, as well as postural disorders, caused by non-progressive injury to the immature brain1,2. It can be classified according to the topographical presentation as monoplegia, hemiplegia, diplegia, and quadriplegia2 . These obvious motor difficulties are frequently accompanied by cognitive disturbances and other neurologic difficulties3 . CP is considered the most prevalent mobility disorder in children, with an average frequency of 3 per 1,000 live births worldwide and a high prevalence of 60 to 150 per 1,000 among preterm infants who are born weighing less than 1,500 g 4 . Hemiplegic CP accounts for 21% to 40% of all cases of CP5,6.

Impairments in the upper extremity (UE) are a major factor for activity limitation and participation restriction in individuals with CP and may affect up to 50% of CP subjects \[7\]. UE limitations are mostly due to a lack of trunk control, decrease in shoulder girdle motor control and imbalance between spastic and paretic muscles \[8\]. That makes it difficult for people with CP to perform UE-specific tasks, such as reaching, grasping and manipulation, and it leads to the significant involvement of the positioning and functioning of the elbows, wrists and hands . Moreover, a lack of autonomy and dependence on other people may affect the individuals' quality of life \[9\].

Pulley therapy is a part of universal exercise unit which formed of spider cage and a system of pulley, straps and weights for resistance. It is a new method used for strengthening of weak muscles by isolating the target specific muscle for training \[10\] . There are several benefits of pulley therapy as: improving passive/active ROM, flexibility of muscle, enhancing strength and endurance of muscle without any associated movement and improving functional skills and dynamic movement \[11\] .

So, this study was conducted to investigate the effect of pully system exercise in improvement of upper limb function in hemiplegic cerebral palsy children

Subjects materials and methods:

Randomized controlled double blinded study design was used. The study will be conducted at El salam university out- patient clinic between June 2024 and August 2024 Subjects G power v2.1.9.7 was used to calculate proper sample size based on pilot testing that revealed effect size of 1.05. the proposed sample size is 32 when using alpha of 0.05 and power of 80%.

The sample size will equal 32 (randomly divided into two group) study group will receive poly system exercise on upper limb, Control group will receive designed physical therapy programme.

Once participants meet the inclusion criteria and consent to participate, they are randomly assigned to either the intervention group (receiving pulley system exercises in addition to standard care) or the control group (receiving standard care). Use a computer-generated random number table or software to assign participants.

The therapists or researchers who conduct the evaluations (e.g., AHA, BOT-2, QUEST) will not be informed of the participant's group assignment. This can be achieved by using different individuals to provide the intervention and assess the outcomes, or by ensuring that assessment data are coded in such a way that the assessor does not know the group codes.

Participants will be randomly assigned to one of two groups:

Group (A): Intervention Group: 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP.

Group (B): Control Group: Children will receive designed physical therapy program for CP only.

Eligibility criteria: Inclusion Criteria

* Children aged between 3 and 7 years.
* Diagnosed with hemiplegic cerebral palsy, confirmed by a pediatric neurologist.
* Ability to follow simple instructions and participate in exercise sessions.
* Presence of upper limb motor function deficits attributable to hemiplegic cerebral palsy.

Exclusion Criteria

1. Children with additional neurological disorders or severe cognitive impairments that might interfere with the ability to participate in exercise regimens.
2. Recent surgery (within the last 6 months) on the upper limbs.
3. Children who have been involved in similar rehabilitation programs in the past 3 months.
4. Severe uncontrolled medical conditions such as cardiac or respiratory diseases. Presence of any contraindication to physical activity as advised by a medical professional.

Primary outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: 3 months
measure: The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) for Hand Function
timeFrame: 3 months
measure: Quality Upper Extremity Skills Test (QUEST)
timeFrame: 3 months
measure: Lafayette Manual Muscle Tester
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy, Kafrelsheik university
Study officials:
affiliation: Department of pediatric physical therapy and its surgery, Elsalam University
name: Ahmed salim, PHD
role: STUDY_DIRECTOR
affiliation: Paediatric physical therapy department, Kafrelsheik University
name: Sara Elsebahy, PHD
role: STUDY_DIRECTOR
affiliation: Basic science department, kafrelsheik university
name: Ahmed Ali M Torad, PHD
role: PRINCIPAL_INVESTIGATOR
References: