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

NCT ID: NCT05945953

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy, Spastic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Incentive spirometer as visual feedback

Group Type EXPERIMENTAL

Incentive spirometer as visual feedback

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Diaphragmatic breathing exercise (Mirror mediated therapy)

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Incentive spirometer as visual feedback

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

Diaphragmatic breathing exercise (Mirror mediated therapy)

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad Iqbal Tariq, MSCPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NIRM (National Institute of Rehabilitation Medicine

Islamabad, Federal, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/01541 Ayesha Khalid

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.