Spastic Diplegia Cerebral PalsyNCT06064357
Comparison of Massage Therapy and Tissue Flossing Technique
A study testing Transverese friction massage and tissue floss technique in people with Spastic Diplegia Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- What is being tested?
- Transverese friction massage and tissue floss technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Mar 2023to 28 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Helping Hand For Relief and Development Quetta
Quetta, Balochistan, 87300
Lal Gul Khan, MScNMPT, 03002146287, lalgul.khan@riphah.edu.pk
Nemra Shah, MSPT(OMPT), 03331250506, nemrashah3@gmail.com
About this study
Official title: Comparison of Massage Therapy and Tissue Flossing Technique in Children With Diplegic Cerebral Palsy
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.
Read the 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.
- Conditions
- Spastic Diplegia Cerebral Palsy
- Being tested
- Transverese friction massage and tissue floss technique
- Keywords
- Massage Therapy, Tissue Flossing, Diplegia cerebral palsy,
- Medical subject headings
- Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverese friction massage and tissue floss techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Transverese friction massage and tissue floss technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Base Line measurement before start of treatment and post 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start21 Mar 2023
- Primary completion5 Jan 2024 (estimated)
- Study completion28 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegia Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lal Gul Khan, MScNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064357
- Sponsor's protocol ID
- NEMRA SHAH REC/PT/01591
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29074060Rasool 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.
PubMed 28065961Sadowska 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.
PubMed 32606703Yuan 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.
PubMed 30299526Lee 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.
PubMed 31311250Pavone 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.
PubMed 33396243Dimitrijević 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.
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.
PubMed 17355474Raut 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.
Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
PubMed 31174382Bingöl 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.
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.
PubMed 34093228Chang 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.
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.
PubMed 3229564Kaneda 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Massage Therapy and Tissue Flossing Technique in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06064357
- Acronym / sponsor ID
- NEMRA SHAH REC/PT/01591
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- Massage Therapy, Tissue Flossing, Diplegia cerebral palsy,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 5 Jan 2024 (estimated)
- Study completion
- 28 Jan 2024 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transverese friction massage + Conventional Physio Therapy | Experimental | Other: Transverese friction massage and tissue floss techniqueTransverse 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 flossing technique + Conventional Physio Therapy | Experimental | Other: Transverese friction massage and tissue floss techniqueTissue 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverese friction massage and tissue floss techniqueTransverse 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. | Other | Tissue flossing technique + Conventional Physio Therapy, Transverese friction massage + Conventional Physio Therapy |
Primary outcome
Goniometery
Time frame: Base Line measurement before start of treatment and post 6th Week
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
Time frame: Base Line measurement before start of treatment and post 6th Week
Muscle length test of rectus femoris, hip adductors, hamstring, gastrocnemius and soleus will be performed to determined muscular flexibility (17).
Functional mobility scale
Time frame: Base Line measurement before start of treatment and post 6th Week
It is an instrument that measures the available range of motion at a joint. Functional mobility scale will be used to determined mobility (18).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 29074060Monokwane 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.
- Background: PubMed 28065961Rasool 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.
- Background: PubMed 32606703Sadowska 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.
- Background: PubMed 30299526Yuan 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.
- Background: PubMed 31311250Lee 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.
- Background: PubMed 33396243Pavone 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.
- BackgroundDimitrijević 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: PubMed 17355474Macgregor 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.
- BackgroundRaut 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: PubMed 31174382Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
- BackgroundBingöl 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: PubMed 34093228Konrad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lal Gul Khan, MScNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverese friction massage and tissue floss technique in people with Spastic Diplegia Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometery (time frame: Base Line measurement before start of treatment and post 6th Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064357, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.