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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Sham intervention; Other: Chiropractic Care; Other: Physical therapy intervention

• Registration Number: NCT05315102
• Lead Sponsor: Riphah International University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-03-30
• Study Start: 2022-04-07
• Study First Posted: 2022-04-07
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham intervention	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.
Experimental group	Physical therapy intervention	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.
Control group	Physical therapy intervention	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.
Experimental group	Chiropractic Care	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.

Primary Outcome Measures

Name	Time	Method
Canadian Occupation Performance Measure (COPM)	3 weeks	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.
Smartphone app for gait and Balance Assessment	3 weeks	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.
Trunk Control Measurement Scale (TCMS)	3 weeks	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.
Cerebral Palsy Quality Of Life scale (CP-QOL)	3 weeks	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.
Gross Motor Function Measure	3 weeks	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.
Melbourne Assessment of Unilateral Upper Limb Function (MUUL)	3 weeks	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.

Trial Locations

Locations (1)

National Institute of rehabilitation medicine.; 🇵🇰 Islamabad, Federal, Pakistan