Clinical trial NCT06753812: Investigation of the Effect of Constraint Induced Movement Therapy Applied to the Lower Extremity on Lower Extremity Functions in Individuals With Unilateral Cerebral Palsy
Official title: Investigation of the Effect of Constraint Induced Movement Therapy Applied to the Lower Extremity on Balance, Gait and Lower Extremity Functions in Individuals With Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cerebral Palsy Spastic Hemiplegic
Keywords: cerebral palsy
Surface Electromiyography
lower extremity
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups with a conventional therapy control group
Primary purpose: TREATMENT

Brief summary: Lower extremity constraint induced movement therapy has been applied to individuals with multiple sclerosis, stroke, subacute and chronic hemiparesis in recent years and positive results have been reported. However, there is no study in the literature regarding the application of this treatment method to the pediatric population. In order to address this gap in the literature, we planned to conduct this study to examine the possible effects of lower extremity constraint induced movement therapy on lower extremity functions, balance and gait parameters in individuals with cerebral palsy.

Detailed description: Cerebral palsy (CP) is an umbrella term covering a group of non-progressive motor disorder syndromes secondary to lesions or anomalies in the immature brain. The global prevalence of CP is 1.5-3.8 per 1000 births. The most common problems in CP are motor disorders such as spasticity or hypotonia due to imbalance in muscle tone, posture disorders, uncontrolled movements and coordination disorders. Motor disorders are often accompanied by sensory, perceptual, cognitive, communication and behavioral problems, epilepsy and secondary musculoskeletal problems.

The European Cerebral Palsy Monitoring Group has divided SP into 3 classes: spastic, dyskinetic and ataxic types. The spastic type is divided into 2 types: unilateral spastic type SP, where one half of the body is affected, and bilateral spastic type SP, where both halves of the body are affected. Individuals with unilateral SP have low muscle tone, and increased muscle tone and increased reflexes are seen in the later stages. Due to antagonist muscle weakness, there is inability to perform quality lower extremity movements and maintain balance.

In the rehabilitation of individuals with CP, many treatment concepts with high evidence levels are used, such as action observation therapy, bimanual intensive training, treadmill training with partial body weight, hippotherapy, and target-oriented training, which are frequently studied in the literature. Constraint induced movement therapy is also one of the treatment methods that has been frequently used in recent years and has been proven to have positive effects in children with CP. Constraint induced movement therapy (CIMT) is a translational motor rehabilitation technique following CNS injury. The original concept involved restricting the unaffected extremity and forcing the affected extremity. Subsequent studies in humans included voluntary collective tasks or shaping practices with the affected extremity. As a result, CIMT has been reported to be effective in improving real-world arm use, motor function, and kinematic outcomes by causing changes in brain functions and structures. However, many changes have been made to the original protocol of CIMT over the years, including but not limited to the length of time for task practice, restriction, and the use of a transfer package.

CIMT has a very strong evidence base with studies. CIMT for the lower extremity is an intensive intervention method that has recently been reported with good results, based on a modification of the original CIMT for the upper extremity. The applicability of the protocol for the upper extremity may be due to the unilateral nature of the use of these extremities in most of our daily living activities. This may seem difficult for the lower extremities because humans are bipedal and this requires them to use both extremities simultaneously in daily living activities, especially walking. However, the positive results in the recovery of upper extremity motor function following CIMT and its contribution to improving the neurophysiological functions of the brain have convinced the neuroscience community to consider translating the technique to the lower extremities. CIMT also increases the expression of Growth-Associated Protein 43 (GAP 43) and the number of ΔFosB-positive cells, some of the biomarkers that play important roles in neural cell proliferation and neural and synaptic plasticity. Similarly, lower extremity movement is critical to brain health because decreased mobility results in decreased neural stem cell proliferation and altered cell turnover. Consequently, a lower extremity CIMT protocol is designed to include an intensive practice protocol with the predominantly affected extremity, shaping activities, transfer wrapping, and encouragement of increased use of the affected extremity. So far, there are several studies investigating the effects of lower extremity CIMT on walking parameters, balance, and motor function using different study designs, such as case reports, experimental studies, quasi-experimental studies, and randomized controlled trials. These studies reported that lower extremity CIMT improved walking speed, step length, motor function, functional mobility, balance, and kinematic outcomes.

Lower extremity constraint induced movement therapy has been applied to individuals with multiple sclerosis, stroke, subacute and chronic hemiparesis in recent years and positive results have been reported. However, there is no study in the literature regarding the application of this treatment method to the pediatric population. In order to address this gap in the literature, we planned to conduct this study to examine the possible effects of lower extremity constraint induced movement therapy on lower extremity functions, balance and gait parameters in individuals with cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with Cerebral Palsy by a Child Neurologist.
* Having been classified as Unilateral Cerebral Palsy according to SCPE.
* Being between the ages of 5-15,
* Being at levels I-II according to the Gross Motor Function Classification System
* Being at levels I-II according to the Communication Function Classification System
* Being able to stand up from sitting independently, even with the help of the upper extremity
* Being able to walk at least 10 m with or without an assistive device

Exclusion Criteria:

* Children who have had lower extremity orthopedic surgery within the last six months
* Children who have had lower extremity Botox injections within the last six months
* Those with rigid contractures involving lower extremity joints,
* Children with levels III-IV according to the Communication Functions Classification System
* Families and children who do not accept full participation in treatment

Primary outcomes:
measure: Surface EMG
timeFrame: 6 weeks
Secondary outcomes:
measure: Modified Tardieu Scale
timeFrame: 6 weeks
measure: Gross Motor Function Measure (GMFM-88 Dimensions D and E)
timeFrame: 6 weeks
measure: Selective Control Assessment of the Lower Extremity- SCALE
timeFrame: 6 weeks
measure: Observational Gait Analysis-OGS
timeFrame: 6 weeks
measure: Gross Motor Function Classification System
timeFrame: 6 weeks
measure: Timed Up and Go Test
timeFrame: 6 weeks
measure: Pediatric Balance Scale
timeFrame: 6 weeks
measure: Gillette functional gait assessment questionnaire
timeFrame: 6 weeks
measure: Weight Transfer Test
timeFrame: 6 weeks
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: 6 weeks
measure: Goal Attaintment Scale (GAS)
timeFrame: 6 weeks
measure: Impact on Family Scale (IPFAM)
timeFrame: 6 weeks
measure: Communication Function Classification System (CFCS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University Faculty of Health Sciences
Study officials:
References: