Clinical trial NCT05032703: Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in cp
Official title: Effect of Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in Children With Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Diplegia
Keywords: Cerebral palsy / Arm ergometer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of the current study are to:

Define and compare between the efficacy of arm ergometer versus stabilization exercises on trunk control, hand grip power and upper limb quality of functions in children with diplegia.

Detailed description: Studies have shown that the cycle ergometer exercise improves several parameters, such as muscle strength and endurance, along with torso control in sitting position. However, these results are presented only in a small sample. Studies with the use of cycle ergometer in the population with CP are still few and present little information about the physiological effects .Previous studies on children with CP focused on the effect of ergometer on the upper and lower extremities functions. Limited literature is available regarding the effect of arm ergometer on trunk control among this population. The current study will be carried out to define the effect of arm ergometer versus stabilization exercises on trunk control, hand grip power, upper limb function in children with diplegia.

Eligibility criteria: Inclusion Criteria:

1. Age ranges from six to ten years.
2. Grade of spasticity 1 to 2 according to Modified Ashworth scale.
3. Level II and III according to gross motor functional classification system.
4. Level I-III according to manual ability classification system.
5. Able to follow verbal commands and instructions included in both test and training.

Exclusion Criteria:

1. Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
2. Structural or fixed soft tissue deformities of the upper extremities.
3. Neurological or orthopedic surgery in the past 12 months in the upper extremities.
4. Botox injection in the upper extremities in the past 6 months.

Primary outcomes:
measure: Trunk control
timeFrame: 30 minutes
measure: Upper extremity functions
timeFrame: 30/45 minutes
Secondary outcomes:
measure: Hand grip strength
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy - Cairo university
Study officials:
affiliation: Cairo University
name: Amira M Abd El Monem, Prof.dr
role: STUDY_CHAIR
affiliation: Cairo University
name: Amira F Hamed, Dr
role: STUDY_DIRECTOR
affiliation: University of Alexandria
name: Ahmed R Abdel Fadil, Dr
role: STUDY_DIRECTOR
References:
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