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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Incentive spirometer as visual feedback

Diaphragmatic breathing exercise (Mirror mediated therapy)

About this trial

This is an interventional supportive care trial for Cerebral Palsy, Spastic

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NIRM (National Institute of Rehabilitation MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Incentive spirometer as visual feedback

Diaphragmatic breathing exercise (Mirror mediated therapy)

Arm Description

Outcomes

Primary Outcome Measures

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

Forced vital Capacity (FVC)

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

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

Secondary Outcome Measures

Quality of life questionnaire for children (CPQOL-Child)

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)

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

Full Information

NCT ID

NCT05945953

First Posted

July 7, 2023

Last Updated

September 26, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05945953

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 10, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Spastic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Incentive spirometer as visual feedback

Arm Type

Experimental

Arm Title

Diaphragmatic breathing exercise (Mirror mediated therapy)

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Incentive spirometer as visual feedback

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Diaphragmatic breathing exercise (Mirror mediated therapy)

Intervention Description

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 Outcome Measure Information:

Title

Forced Expiratory Volume in 1 second (FEV1)

Description

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

Time Frame

6 weeks

Title

Forced vital Capacity (FVC)

Description

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

Time Frame

6 weeks

Title

Peak Expiratory Flow (PEF)

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Quality of life questionnaire for children (CPQOL-Child)

Description

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

Time Frame

6 weeks

Title

Sleep (Sleep Disturbance Scale-SDSC)

Description

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Iqbal Tariq, MSCPPT

Phone

03338236752

Email

iqbal.tariq@riphah.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Iqbal Tariq, MSCPPT

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

NIRM (National Institute of Rehabilitation Medicine

City

Islamabad

State/Province

Federal

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qammar Mehmood, PhD

Phone

03335151063

First Name & Middle Initial & Last Name & Degree

Ayesha Khalid, MSPT*

First Name & Middle Initial & Last Name & Degree

Qammar Mehmood, PhD

12. IPD Sharing Statement

Plan to Share IPD

No

Cerebral Palsy, Spastic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial