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Completed

NCT Number: NCT05945953

Incentive Spirometer as a Visual Feedback in Children With Spastic Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIRM (National Institute of Rehabilitation Medicine

Islamabad, Federal, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Incentive spirometer as visual feedback

Other

Incentive spirometer as deep breathing then UE movement in sitting: Frequency: 2 sets of 10x Intensity: Up to tolerance (hold breath for 2-4 secs). Time: Twice a week Type: Deep breathing exercise UE movement: Gentle ROMs (5 reps)

along with conventional Treatment; Passive stretching of spastic muscles, Strengthening of weak muscles using manual resistance, Diaphragmatic Breathing, Resisted Diaphragmatic Breathing (placing 5Ib sandbag on abdomen).

Diaphragmatic breathing exercise (Mirror mediated therapy)

Other

Diaphragmatic breathing exercise (Mirror mediated therapy): In front of mirror deep breathing with UE movement in sitting: Frequency: 1 cycle of 10x Intensity: Up to tolerance. Time: 3 times per week. Type: Deep breathing exercise. UE movement: Gentle ROMs (5 reps).

along with conventional Treatment; Passive stretching of spastic muscles, Strengthening of weak muscles using manual resistance, Diaphragmatic Breathing, Resisted Diaphragmatic Breathing (placing 5Ib sandbag on abdomen).

Primary outcomes

  1. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 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

  2. Forced vital Capacity (FVC)

    Time frame: 6 weeks

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

  3. Peak Expiratory Flow (PEF)

    Time frame: 6 weeks

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second

Secondary outcomes

  1. Quality of life questionnaire for children (CPQOL-Child)

    Time frame: 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

  2. Sleep (Sleep Disturbance Scale-SDSC)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparison of Incentive Spirometer as a Visual Feedback Versus Deep Breathing Via Mirror Mediated Therapy on Pulmonary Function in Children With Spastic Cerebral Palsy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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