NCT06064357

Brief Summary

The purpose of the study is to compare massage therapy with tissue flossing technique in children with diplegic cerebral palsy. A randomized control trial would be conducted at helping hand for relief and development Quetta. The sample size is 56 calculated through G power. The participants would be divided into two interventional groups each having 28 participants. The study duration would be six weeks. Sampling technique applied would be convenient sampling for recruitment and group randomization via using envelop method. Tools used in this study are Goniometer, muscle length test and Functional Mobility scale. Data would be collected before and after 6 weeks of the application of interventions. Data analyzed through SPSS version 23.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 21, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 26, 2023

Last Update Submit

September 26, 2023

Conditions

Keywords

Massage Therapy, Tissue Flossing, Diplegia cerebral palsy,

Outcome Measures

Primary Outcomes (3)

  • Goniometery

    It is an instrument that measures the available range of motion at a joint. It will used to determine range of motion of hip, knee and ankle joint (16).

    Base Line measurement before start of treatment and post 6th Week

  • Muscle length test

    Muscle length test of rectus femoris, hip adductors, hamstring, gastrocnemius and soleus will be performed to determined muscular flexibility (17).

    Base Line measurement before start of treatment and post 6th Week

  • Functional mobility scale

    It is an instrument that measures the available range of motion at a joint. Functional mobility scale will be used to determined mobility (18).

    Base Line measurement before start of treatment and post 6th Week

Study Arms (2)

Transverese friction massage + Conventional Physio Therapy

EXPERIMENTAL

Transverse friction massage: Transverse friction massage at Rectus femoris, hip adductors, hamstring, and calf muscle on both lower limbs. TFM on each group of muscle for 30 seconds, 3 sets with 10 seconds rest interval after that massage will be performed on next group of muscle.4 session per week lasting for 6 weeks. Conventional Therapy: Conventional physical therapy program included application hot pack for 15 minutes, and Bobath treatment followed by stretching of calf muscles (10 repetitions with at least 8 seconds hold) 4 times a week lasting for 6 weeks

Other: Transverese friction massage and tissue floss technique

Tissue flossing technique + Conventional Physio Therapy

EXPERIMENTAL

Tissue floss bands: These band will be applied on Rectus femoris, hip adductors, calf muscle and hamstring muscle of both lower limbs. Floss band will be wrap around the particular group of muscle from distal to proximal direction with 25 % stretch and 50% overlap a few inches below and few inches above the area and then 10 Reps of rom will be actively performed by the participants and then after 10 Reps remove the band and the rest interval is 2 mint after that next group of muscle will be wrap. 4 sessions per week lasting for 6 weeks. Conventional Therapy: Conventional physical therapy program included application hot pack for 15 minutes, and Bobath treatment followed by stretching of calf muscles (10 repetitions with at least 8 seconds hold) 4 times a week lasting for 6 weeks.

Other: Transverese friction massage and tissue floss technique

Interventions

Transverse friction massage at Rectus femoris, hip adductors, hamstring, and calf of both lower limbs. TFM on each group of muscle for 30 seconds, 3 sets with 10 seconds rest interval.4 session / week for 6 weeks. Tissue floss band will be applied on Rectus femoris, hip adductors, calf and hamstring of both lower limbs. Floss band will be wrap around the particular group of muscle from distal to proximal direction with 25 % stretch and 50% overlap and then 10 Reps of rom will be performed the rest interval is 2 mint. 4 sessions / week for 6 weeks. Conventional physical therapy program included application hot pack for 15 minutes, and Bobath treatment followed by stretching of calf (10 repetitions with at least 8 seconds hold) 4 times / week for 6 weeks.

Tissue flossing technique + Conventional Physio TherapyTransverese friction massage + Conventional Physio Therapy

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants falling in this category would be recruited into the study.
  • Both genders (male and female).
  • Age between 12 - 15 years.
  • Diagnosed patients of spastic diplegic cerebral palsy.
  • Muscle tone between (1 and 1+) according to modified Ashworth scale.
  • Gross motor function classification system level will be from I to IV.
  • Children who has communication skills (according to communication function classification system, level I - III).

You may not qualify if:

  • Participants falling in this category would be excluded from the study.
  • Previous Fracture/Trauma of lower limb less than six month prior to the study.
  • Soft tissue injury of lower limb less than six month prior to the study.
  • History of any surgical intervention for the management of spasticity or any orthopedic surgery of lower limb.
  • Any therapeutic intervention for the management of spasticity i-e (botulinum injections, ITB and drugs) less than six month prior to the study.
  • Children with multiple disabilities.
  • Seizure.
  • Latex allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand For Relief and Development Quetta

Quetta, Balochistan, 87300, Pakistan

RECRUITING

Related Publications (17)

  • Monokwane B, Johnson A, Gambrah-Sampaney C, Khurana E, Baier J, Baranov E, Westmoreland KD, Mazhani L, Steenhoff AP, Bearden DR. Risk Factors for Cerebral Palsy in Children in Botswana. Pediatr Neurol. 2017 Dec;77:73-77. doi: 10.1016/j.pediatrneurol.2017.07.014. Epub 2017 Aug 3.

    PMID: 29074060BACKGROUND
  • Rasool F, Memon AR, Kiyani MM, Sajjad AG. The effect of deep cross friction massage on spasticity of children with cerebral palsy: A double-blind randomised controlled trial. J Pak Med Assoc. 2017 Jan;67(1):87-91.

    PMID: 28065961BACKGROUND
  • Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.

    PMID: 32606703BACKGROUND
  • Yuan J, Wang J, Ma J, Zhu D, Zhang Z, Li J. Paediatric cerebral palsy prevalence and high-risk factors in Henan province, Central China. J Rehabil Med. 2019 Jan 1;51(1):47-53. doi: 10.2340/16501977-2486.

    PMID: 30299526BACKGROUND
  • Lee H, Kim EK, Son DB, Hwang Y, Kim JS, Lim SH, Sul B, Hong BY. The Role of Regular Physical Therapy on Spasticity in Children With Cerebral Palsy. Ann Rehabil Med. 2019 Jun;43(3):289-296. doi: 10.5535/arm.2019.43.3.289. Epub 2019 Jun 28.

    PMID: 31311250BACKGROUND
  • Pavone P, Gulizia C, Le Pira A, Greco F, Parisi P, Di Cara G, Falsaperla R, Lubrano R, Minardi C, Spalice A, Ruggieri M. Cerebral Palsy and Epilepsy in Children: Clinical Perspectives on a Common Comorbidity. Children (Basel). 2020 Dec 31;8(1):16. doi: 10.3390/children8010016.

    PMID: 33396243BACKGROUND
  • Dimitrijević L, Čolović H, Spalević M, Stanković A, Zlatanović D, Cvetković B. Assessment and treatment of spasticity in children with cerebral palsy. Acta Facultatis Medicae Naissensis. 2014;31(3):163-9.

    BACKGROUND
  • Macgregor R, Campbell R, Gladden MH, Tennant N, Young D. Effects of massage on the mechanical behaviour of muscles in adolescents with spastic diplegia: a pilot study. Dev Med Child Neurol. 2007 Mar;49(3):187-91. doi: 10.1111/j.1469-8749.2007.00187.x.

    PMID: 17355474BACKGROUND
  • Raut A, Risaldar P, Naqvi WM, Wane M, Sahu A. Case report of a spastic diplegic cerebral palsy patient: Clinical decision making in physical therapy. 5. Medical Science. 2020;24(103):1809-13.

    BACKGROUND
  • Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.

    PMID: 31174382BACKGROUND
  • 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
  • Konrad A, Mocnik R, Nakamura M. Effects of Tissue Flossing on the Healthy and Impaired Musculoskeletal System: A Scoping Review. Front Physiol. 2021 May 21;12:666129. doi: 10.3389/fphys.2021.666129. eCollection 2021.

    PMID: 34093228BACKGROUND
  • Chang N-J, Hung W-C, Lee C-L, Chang W-D, Wu B-H. Effects of a single session of floss band intervention on flexibility of thigh, knee joint proprioception, muscle force output, and dynamic balance in young adults. Applied Sciences. 2021;11(24):12052.

    BACKGROUND
  • Stuberg WA, Fuchs RH, Miedaner JA. Reliability of goniometric measurements of children with cerebral palsy. Dev Med Child Neurol. 1988 Oct;30(5):657-66. doi: 10.1111/j.1469-8749.1988.tb04805.x.

    PMID: 3229564BACKGROUND
  • Kaneda H, Takahira N, Tsuda K, Tozaki K, Sakai K, Kudo S, et al. The effects of tissue flossing and static stretching on gastrocnemius exertion and flexibility. Isokinetics and Exercise Science. 2020;28(2):205-13.

    BACKGROUND
  • Pawar A, Phansopkar P, Gachake A, Mandhane K, Jain R, Vaidya S. A review on impact of lower extremity muscle Length. J Pharm Res Int. 2021;33(35A):158-64.

    BACKGROUND
  • Ammann-Reiffer C, Bastiaenen CHG, Van Hedel HJA. Measuring change in gait performance of children with motor disorders: assessing the Functional Mobility Scale and the Gillette Functional Assessment Questionnaire walking scale. Dev Med Child Neurol. 2019 Jun;61(6):717-724. doi: 10.1111/dmcn.14071. Epub 2018 Oct 19.

    PMID: 30341775BACKGROUND

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic

Study Officials

  • Lal Gul Khan, MScNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Transverse friction massage at Rectus femoris, hip adductors, hamstring, and calf of both lower limbs.Applied time is 30 seconds, 3 sets with 10 seconds rest interval after that massage will be performed on next group of muscle.4 time / week for 6 weeks. Conventional physical therapy program included application hot pack for 15 minutes, and Bobath treatment followed by stretching of calf muscles (10 repetitions with at least 8 seconds hold) 4 times / week for 6 weeks. Tissue floss band will be applied on Rectus femoris, hip adductors, calf and hamstring of both lower limbs. Floss band will be wrap around the particular muscle from distal to proximal direction with 25 % stretch and 50% overlap and then 10 Reps of rom will be actively performed and then the rest interval is 2 mints. 4 sessions / week for 6 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

March 21, 2023

Primary Completion

January 5, 2024

Study Completion

January 28, 2024

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations