NCT05392335

Brief Summary

Cerebral palsy is one of the most common childhood disabilities, and it occurs with an incidence of 2-2.5 per 1000 living births. Children with CP have various impairments including neuromuscular and musculoskeletal problems such as spasticity, dyscoordination, loss of selective motor control, and weakness. CP can be classified according to the severity of motor deficits as mild, moderate, or severe. Several other classification systems exist based on the pathophysiology, etiology, and distribution of motor deficits. The aim of the study to evaluate the effects of functional massage and myofascial stretch on spasticity and motor function of CP Children. Study will be conducted in 22 patients in experimental and control group. Pre and Post values will be evaluated. The tools used will be Modified Ashworth Scale (MAS) and Gross Motor Function Measure (GMFM). The significance of this study is that it will define for us that to how much extent we can improve the Spastic and painful condition of lower limb of CP child. Data will be analyzed using SPSS 22.0 mean and standard deviation will be calculated. Appropriate the statistical test will be used after checking normality of data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

May 23, 2022

Last Update Submit

March 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in scores of Modified Ashworth scale

    The modified Ashworth scale(MAS) is a 6-point rating scale that is used to measure muscle tone.(20) The reliability of the modified Ashworth scale was very good (κw = .84 for inter rater and .83 for intra-rater comparisons)

    Baseline and 8th week

  • Change in scores of GMFM 88

    The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1 = initiates 2 = partially completes 3 = completes 9 (or leave blank) = not tested (NT)

    Baseline and 8th week

Study Arms (2)

myofascial stretch group

ACTIVE COMPARATOR

Patients will be given myofascial stretch

Other: Myofascial stretch

Functional massage along with myofascial stretch group

EXPERIMENTAL

patients will be given functional massage along with myofascial stretching

Other: Myofascial stretchOther: Functional massage along with myofacial stretch

Interventions

Myofascial stretch will be applied at hip adductors, hamstrings and calf muscles for 10 -15 repetitions on each muscle. 2-3 sessions will be performed in a week for 8 weeks.

Functional massage along with myofascial stretch groupmyofascial stretch group

In this group during the first 20 minutes, ten minutes FM will be applied to each lower extremity of the subject. The muscle groups to which FM would be applied were hip adductors, hamstrings and calf muscles. During the remaining period traditional physiotherapy involving myofascial strecth will be given. 2-3 session will be performed in a week for 8 weeks.

Functional massage along with myofascial stretch group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age of 6 and 12 year
  • Both genders
  • Children between level Ⅰ- Ⅳ based on Gross Motor Classification System(GMFCS)

You may not qualify if:

  • The existence of dyskinesia or dystonia
  • History of muscle lengthening surgery
  • Presence of uncontrolled seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute

Lahore, Punjab Province, 64000, Pakistan

Location

Related Publications (4)

  • Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019 Sep-Oct;35(5):1210-1215. doi: 10.12669/pjms.35.5.478.

    PMID: 31488980BACKGROUND
  • BİNGÖL H, YILMAZ Ö. Effects of functional massage on spasticity and motor functions in children with cerebral palsy: a randomized controlled study. Journal of Exercise Therapy and Rehabilitation. 2018;5(3):135-42.

    BACKGROUND
  • Bingöl H, Akaras E, Kocaman H. The effects of massage therapy on symptoms related cerebral palsy in children with cerebral palsy: A systematic review. Journal of Clinical Medicine of Kazakhstan. 2020;4(58):6-14.

    BACKGROUND
  • Kuruma H, Takei H, Nitta O, Furukawa Y, Shida N, Kamio H, et al. Effects of Myofascial Release and Stretching Technique on Range of Motion and Reaction Time. Journal of Physical Therapy Science. 2013;25(2):169-71.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Fareeha Kausar, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 13, 2022

Primary Completion

January 16, 2023

Study Completion

January 20, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations