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

NCT05945953 | Completed DMC

• 1 other identifier: REC/01541 Ayesha Khalid
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (3)

• Forced Expiratory Volume in 1 second (FEV1)

  Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

  6 weeks

• Forced vital Capacity (FVC)

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

  6 weeks

• Peak Expiratory Flow (PEF)

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

  6 weeks

Secondary Outcomes (2)

• Quality of life questionnaire for children (CPQOL-Child)

  6 weeks

• Sleep (Sleep Disturbance Scale-SDSC)

  6 weeks

Study Arms (2)

Incentive spirometer as visual feedback

EXPERIMENTAL

Other: Incentive spirometer as visual feedback

Diaphragmatic breathing exercise (Mirror mediated therapy)

ACTIVE COMPARATOR

Other: Diaphragmatic breathing exercise (Mirror mediated therapy)

Interventions

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).

Incentive spirometer as visual feedback

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).

Diaphragmatic breathing exercise (Mirror mediated therapy)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

NIRM (National Institute of Rehabilitation Medicine

Islamabad, Federal, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Study Officials

• Muhammad Iqbal Tariq, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: September 10, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)