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Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sham intervention
Chiropractic Care
Physical therapy intervention
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants will be recruited into the study according to the following criteria.

  • Both gender (Male and Female).
  • Age between 2 to 15 years.
  • Spastic Cerebral Palsy children.

Exclusion Criteria:

Participants will be excluded from the study according to the following criteria.

  • Cerebral Palsy children due to Traumatic Brain Injury.
  • Patients having cognitive impairments.
  • Patients having associated Neurological Pathologies.
  • Patients who are unable to follow treatment plan.

Sites / Locations

  • National Institute of rehabilitation medicine.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.

The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.

Outcomes

Primary Outcome Measures

Gross Motor Function Measure
The gross motor function measure is a standard instrument that measures the change in motor function with time in Cerebral palsy subjects. It assesses the number of motor tasks a child can perform. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. the higher score, the greater is Gross motor function.
Trunk Control Measurement Scale (TCMS)
TCMS is an extended version of the trunk impairment scale with a total score of 58, which assesses the quality of static and dynamic trunk control. The maximum value for the total TCMS is 58 points (20 for the category 'static sitting balance', 28 for 'selective movement control', and 10 for 'dynamic reaching'). A higher TCMS score indicates better performance in trunk control.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered as one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Scoring is completed across the 30 score items using a three, four or five-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale.
Canadian Occupation Performance Measure (COPM)
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing them by the number of problems. At reassessment, the client scores each problem again for performance and satisfaction.
Cerebral Palsy Quality Of Life scale (CP-QOL)
The CP-QOL-child is a condition-specific QOL questionnaire designed for children with CP. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The greater the score, the better is the quality of life.
Smartphone app for gait and Balance Assessment
This embedded inertial sensor-based smartphone application can provide a valid and reliable estimation of several gaits and balance parameters. The smartphone app for gait and balance assessment will be used on the subject who can walk independently.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05315102
Brief Title
Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.
Official Title
To Investigate the Effects of Two Weeks of Intensive Chiropractic Care When Added to Usual Care for Children With Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

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
No

5. Study Description

Brief Summary
To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in spastic cerebral Palsy children.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Research
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor.No spinal adjustment will be performed during any control intervention.
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust
Intervention Type
Other
Intervention Name(s)
Chiropractic Care
Intervention Description
A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.
Intervention Type
Other
Intervention Name(s)
Physical therapy intervention
Intervention Description
The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Cerebral Palsy children, where Conventional Therapy will be provided according to the respective needs of the individual patient.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure
Description
The gross motor function measure is a standard instrument that measures the change in motor function with time in Cerebral palsy subjects. It assesses the number of motor tasks a child can perform. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. the higher score, the greater is Gross motor function.
Time Frame
3 weeks
Title
Trunk Control Measurement Scale (TCMS)
Description
TCMS is an extended version of the trunk impairment scale with a total score of 58, which assesses the quality of static and dynamic trunk control. The maximum value for the total TCMS is 58 points (20 for the category 'static sitting balance', 28 for 'selective movement control', and 10 for 'dynamic reaching'). A higher TCMS score indicates better performance in trunk control.
Time Frame
3 weeks
Title
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Description
Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered as one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Scoring is completed across the 30 score items using a three, four or five-point scale and individually defined scoring criteria. Item scores relating to each element of movement measured are summed within the corresponding sub-scale.
Time Frame
3 weeks
Title
Canadian Occupation Performance Measure (COPM)
Description
It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing them by the number of problems. At reassessment, the client scores each problem again for performance and satisfaction.
Time Frame
3 weeks
Title
Cerebral Palsy Quality Of Life scale (CP-QOL)
Description
The CP-QOL-child is a condition-specific QOL questionnaire designed for children with CP. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The greater the score, the better is the quality of life.
Time Frame
3 weeks
Title
Smartphone app for gait and Balance Assessment
Description
This embedded inertial sensor-based smartphone application can provide a valid and reliable estimation of several gaits and balance parameters. The smartphone app for gait and balance assessment will be used on the subject who can walk independently.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be recruited into the study according to the following criteria. Both gender (Male and Female). Age between 2 to 15 years. Spastic Cerebral Palsy children. Exclusion Criteria: Participants will be excluded from the study according to the following criteria. Cerebral Palsy children due to Traumatic Brain Injury. Patients having cognitive impairments. Patients having associated Neurological Pathologies. Patients who are unable to follow treatment plan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IMRAN AMJAD, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of rehabilitation medicine.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

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Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.

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