Incentive Spirometer as a Visual Feedback in Children With Spastic Cerebral Palsy
- Conditions
- Cerebral Palsy, Spastic
- Registration Number
- NCT05945953
- Lead Sponsor
- Riphah International University
- Brief Summary
Objective: To compare the effects of incentive spirometer as a visual feedback versus deep breathing via mirror mediated therapy on pulmonary function in children with spastic cerebral palsy. To determine the effects of incentive spirometer as a visual feedback versus deep breathing via mirror mediated therapy on sleep and quality of life in children with spastic cerebral palsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Participants falling in this category would be recruited into the study.
- Spastic diplegic, age above 5.
- According to modified Ashworth scale, moderate spasticity 1 to 3.
- Adequate cognition (will be assessed by using MMSE scale) in order to follow the instructions to use Incentive Spirometry and also able to comprehend single verbal command for breathing.
- Able to attend all sessions. (mentally and physically capable of attending session).
- Able to sit with support.
- Participant falling in this category would be excluded of the study.
- Patients with any respiratory or cardiac disease that can affect their respiratory function.
- Patients with beta blockers or bronchodilators.
- Children with any cognitive impairment who are unable to follow instructions.
- Children with bone deformities, such as scoliosis or kyphosis.
- Children with any sort of auditory and visual defects.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in 1 second (FEV1) 6 weeks Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Peak Expiratory Flow (PEF) 6 weeks Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second
Forced vital Capacity (FVC) 6 weeks Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
- Secondary Outcome Measures
Name Time Method Quality of life questionnaire for children (CPQOL-Child) 6 weeks Changes from the baseline, This questionnaire has been specifically developed for children with cerebral palsy to measure the quality of life. Primary care giver questionnaire (4-12 years). These items can be recorded by the following formula: 1-2 (Very unhappy), 3-4(Unhappy), 5(neither happy nor unhappy), 6- 7(happy), 8-9 (very happy). If person scored 1, record to 0 If person scored 2, record to 12.5 If person scored 3, record to 25 If person scored 4, record to 37.5 If person scored 5, record to 50 If person scored 6, record to 62.5 If person scored 7, record to 75 If person scored 8, record to 87.5 If person scored 9, record to 100
Sleep (Sleep Disturbance Scale-SDSC) 6 weeks This scale has been validated for children aged 6 to 15 years. The questionnaire is completed by caregiver or parents. It has internal consistency 0.71 to 0.79, test-retest reliability of 0.71 and diagnostic accuracy of 0.91. (32, 33) Scoring
It is liker-type scale that indicates the following:
1 means 'never' 5 means 'always' Total score (sum 6 factors' scores) Higher the score indicates more acute sleep disturbances. To obtain results, scores are tallied for each of six sleep disordere
Trial Locations
- Locations (1)
NIRM (National Institute of Rehabilitation Medicine
🇵🇰Islamabad, Federal, Pakistan
NIRM (National Institute of Rehabilitation Medicine🇵🇰Islamabad, Federal, Pakistan