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Comparison of Massage Therapy and Tissue Flossing Technique

Primary Purpose

Spastic Diplegia Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Transverese friction massage and tissue floss technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Diplegia Cerebral Palsy focused on measuring Massage Therapy, Tissue Flossing, Diplegia cerebral palsy,

Eligibility Criteria

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

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

  • Helping Hand For Relief and Development QuettaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transverese friction massage + Conventional Physio Therapy

Tissue flossing technique + Conventional Physio Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06064357
Brief Title
Comparison of Massage Therapy and Tissue Flossing Technique
Official Title
Comparison of Massage Therapy and Tissue Flossing Technique in Children With Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
January 28, 2024 (Anticipated)

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
Yes

5. Study Description

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.
Detailed Description
Cerebral palsy (CP) is a syndrome of motor impairments characterized by non-progressive disturbances taking place in developing fetal and infant brain(1). The most prevalent motor disability in children, CP affects 2 to 3 out of every 1,000 live births. The most prevalent type of CP, spastic CP account for about 80% , especially spastic diplegic, accounts for between 50% and 60% of all cases(2).The term "cerebral paralysis "was used for the first time in 1861, by the English orthopedic surgeon named William Little (3). There are four categories of risk factors for CP: pre-conception, prenatal, perinatal, and postnatal(3, 4). Traditionally, CP has been categorized according to the type of movement dysfunction and anatomical distribution. Spastic, dyskinetic, hypotonic, ataxic, and mixed kinds of movement are among the patterns of movement. Spastic movement is the most prevalent, with dyskinetic, ataxic, or hypotonic movement patterns making up the minority of cases(5). Hemiplegic, diplegic, and quadriplegic made up the anatomic distribution. Only one side of the body is affected in hemiplegic CP, and the upper extremities often show the greatest deficits. Lower extremities are more commonly affected in Diplegic CP than upper extremities. The axial and appendicular skeletons are both affected in Quadra plegic cerebral palsy, which affects the entire body (6). Damage to the brain occurs in CP patients, most frequently in the region of the brain that regulates muscle tone and limb movement. As a result, the brain is powerless to control how flexible a muscle should be. The spinal cord is dominated by the command from the muscle, which causes the muscle to become too tight or spastic(7). Periventricular leukomalacia (PVL), the most prevalent abnormality on neuroimaging, is a white matter anomaly located close to the lateral ventricle. Children with PVL often exhibit spastic diplegia because the corticospinal tract fibers to the lower limbs are medial to those of the upper extremities in the periventricular white matter(3, 8).CP child are diagnosed on the basis of history and physical examination(2). Muscle stiffness and heightened reflexes are side effects of cerebral palsy, which affects mobility and coordination. Either too loose or too rigid a muscle tone. Walking difficulty, such as walking on one's toes or crossing one's knees like a scissor. Inability to use fine motor abilities. Balance and muscle coordination are noticeably absent. Tremors and jerky involuntary movement also present in children with athetoid CP(3,9).Spasticity causes irregular movements in the muscles and joints of the extremities and is particularly damaging to growing youngsters. Any muscle group in the body might be affected by spasticity. Hip flexion, adduction of the thighs, knee flexion, equinovarus foot posture, and hyperextension of the big toe are the effects on the lower limbs.(7). In spastic diplegia the most commonly effected lower limb muscles are gastrocnemius, soleus, adductors, hamstrings, psoas and rectus femoris(2). The treatment of a child with CP requires a multidisciplinary approach(7). Physiotherapy intervention included static and dynamic weight bearing exercises balance training, weight bearing exercises, sustained stretching exercises, Roods approach, Bobath technique, exercises on Swiss ball, orthosis, and proper home exercise program(10).Massage is one of the oldest and most widely used treatments in complementary and alternative medicine, with more than 75 forms of it practiced today(2).Massage has positive effects on muscle tone disorder(11, 12).Mocgregor et al conducted a study in this Transverse-friction massage was applied to the calf muscles of patients with spastic diplegia. They hypothesized that this resets sarcomere length(8).Tissue flossing was first proposed by Starrett and Cordoza (2015), who claimed that it can lessen discomfort from various diseases or injuries, increase range of motion, and/or improve performance (such as strength or leaping performance(13). The flexibility of muscles can be greatly increased with Floss Band intervention(14, 15). Generally, muscles of children with CP lack muscular flexibility. Muscular stiffness results from an increase in muscular tone. Due to muscular stiffness, it was impossible to stretch the muscle properly, which led to the creation of contractures, reduced range of motion (ROM), and restricted mobility. Muscular flexibility is a basic element for muscular action and important milestone in the rehabilitation program for children with CP. Treatment options provided to improve muscles flexibility, rang of motion and mobility of children with CP must not be limited to invasive methods which are also financially expensive. The Tissue flossing is a novice, non-invasive method that depend on an easily held, safe, cheap and light weighted. The use of tissue flossing is becoming a popular strategy in rehabilitation program. However the literature on floss band effectiveness in children with Cp remain sparse. Previously studies have been conducted that support the role of tissue flossing in athletes and in individuals with various musculoskeletal injuries. However its role particularly in CP patients is unavailable. In this research we have incorporated this technique to determine its effects in cerebral palsy children. Therefore, the purpose of this study is to do comparison between transverse friction massage with tissue flossing technique and examine the effects on range of motion, muscular flexibility, and mobility in children with diplegic CP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegia Cerebral Palsy
Keywords
Massage Therapy, Tissue Flossing, Diplegia cerebral palsy,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transverese friction massage + Conventional Physio Therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Tissue flossing technique + Conventional Physio Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Transverese friction massage and tissue floss technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Goniometery
Description
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).
Time Frame
Base Line measurement before start of treatment and post 6th Week
Title
Muscle length test
Description
Muscle length test of rectus femoris, hip adductors, hamstring, gastrocnemius and soleus will be performed to determined muscular flexibility (17).
Time Frame
Base Line measurement before start of treatment and post 6th Week
Title
Functional mobility scale
Description
It is an instrument that measures the available range of motion at a joint. Functional mobility scale will be used to determined mobility (18).
Time Frame
Base Line measurement before start of treatment and post 6th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
0515481826
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lal Gul Khan, MScNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping Hand For Relief and Development Quetta
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lal Gul Khan, MScNMPT
Phone
03002146287
Email
lalgul.khan@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Nemra Shah, MSPT(OMPT)
Phone
03331250506
Email
nemrashah3@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Comparison of Massage Therapy and Tissue Flossing Technique

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