Effects of Shockwave Therapy on Crouched Gait Due to Hamstring Flexibility in Cerebral Palsy Children

NCT06460714 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0775
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Shock wave; Hamstring flexibility; Crouched gait

Outcome Measures

Primary Outcomes (3)

• Modified Ashwarth Scale

  The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement. interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS

  8 weeks

• GMFM-88

  The Gross Motor Function Measure-88 (GMFM-88) is widely used tool for assessing changes in gross motor function among children with cerebral palsy. It comprising 88 items across five domains. GMFM-A includes activities such as lying and rolling, GMFM-B includes sitting, Crawling and kneeling includes in GMFM-C, GMFM-D includes standing and walking, running and jumping includes in GMFM-E. The reliability of GMFM-88 is 0.75 to 1.0.

  8 weeks

• Goniometer

  A goniometer is a measurement tool commonly used in rehabilitation and physical therapy to assess the range of motion (ROM) of various joints in the body. It consists of a stationary arm and a movable arm with a protractor-like scale, allowing for precise measurement of joint angles. By aligning the stationary arm with the joint's axis and the movable arm with the body segment, the goniometer provides objective measurements of joint flexibility, mobility, and muscle strength. The goniometer provides valuable quantitative data that can guide treatment planning, monitor patient progress, and assess functional outcomes related to joint movement and mobility.

  8 weeks

Study Arms (2)

Shock wave therapy, stretching and orthosis

EXPERIMENTAL

Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.

Other: Shock wave therapy, stretching and orthosis

Stretching, strengthening and orthosis

ACTIVE COMPARATOR

In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.

Other: Stretching, strengthening and orthosis

Interventions

Shock wave therapy, stretching and orthosis OTHER

Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.

Shock wave therapy, stretching and orthosis

Stretching, strengthening and orthosis OTHER

In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.

Stretching, strengthening and orthosis

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with GMFCS level I, II \& III.
• Passive range of motion of knee extension is limited to 20 degree with hip 90 degree.
• Age between 6 to 12 years.

You may not qualify if:

• Children with epileptic history
• Previous muscular lengthening technique applied
• Previous history of botox injection used.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Punjab Special School

Lahore, Punjab Province, Pakistan

Location

Related Publications (3)

• Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.

  PMID: 32053326 BACKGROUND

• Lowing K, Arredondo YC, Tedroff M, Tedroff K. Introduction of the gross motor function classification system in Venezuela--a model for knowledge dissemination. BMC Pediatr. 2015 Sep 4;15:111. doi: 10.1186/s12887-015-0433-5.

  PMID: 26341265 BACKGROUND

• Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.

  PMID: 28698802 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Extracorporeal Shockwave Therapy; Orthotic Devices

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Muhammad Fahad Asif, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separated treatment protocols and possible efforts will be put to mask the both groups about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control trial in which non-probability convenient sampling will be used. Both group of spastic CP of age 6 to 12 will be randomly divided. Group A will receive shockwave, stretching and orthosis. Group B will receive stretching and orthosis.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: April 5, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 10, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)