Potential Benefits of Home Based Exercise Programs in the Management of Spastic Cerebral Palsy

NCT05111236 | Unknown DMC

• 1 other identifier: NIRM-Physio/01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted to see the potential benefits of home based exercise program comprising routine physical therapy and traditional massage in the management of spastic cerebral palsy (CP). It will be a randomized controlled trial having two groups, RPT group and Massage group. Both groups will be provided with routine physical therapy treatment comprising stretching of spastic muscles, strengthening of weak muscles, positioning and posturing strategies. Massage group will also receive traditional massage in addition to routine physical therapy. Parents/Caregivers will be trained to perform routine physical therapy and traditional massage at home. Data will collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Measure (GMFM),Gross Motor Function Classification System (GMFCS) and CP Child's Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 6th and 12th weeks of intervention.

Conditions

Cerebral Palsy, Spastic, Diplegic

Keywords

cerebral palsy, massage, spasticity, motor function

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth scale (MAS)

  0 = No increase in muscle tone * 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range Of Motion (ROM) * 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3 = Considerable increase in muscle tone, passive movement difficult. * 4 = Affected part(s) rigid in flexion or extension

  Twelve weeks

Secondary Outcomes (3)

• Gross motor Function Measure (GMFM-88)

  Twelve weeks

• Gross Motor Function Classification System (GMFCS)

  Twelve weeks

• CPCHILD ( Caregiver Priorities & child health index of life with Disabilities

  Twelve weeks

Study Arms (2)

RPT Group

ACTIVE COMPARATOR

Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. This whole regimen will be practiced fives times a week for a period of twelve weeks. Other Names: • Routine Physical Therapy

Other: Routine physical therapy

Massage Group

EXPERIMENTAL

Traditional massage of thirty minutes duration ( five minutes of massage will be provided to all four limbs, front and back of trunk area) prior to routine physical therapy. Routine physical therapy comprising stretching of spastic muscles, Strengthening of weak muscles, positioning ( how to make sitting and standing postures at home) and posturing strategies. Other Names: • Routine physical therapy and Traditional massage

Other: Routine physical therapy; Other: Traditional massage

Interventions

Routine physical therapy OTHER

Rehabilitation strategies in management of children with spastic CP

Massage Group; RPT Group

Traditional massage OTHER

Rehabilitation strategies in management of children with spastic CP

Massage Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child should have established diagnosis of spastic cerebral palsy (diplegic types only).

You may not qualify if:

• Children having moderate to severe contractures.
• Children having moderate to severe mental retardation and with multiple disabilities.
• Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and behavioral disorders

Sponsors & Collaborators

• National Institute of Rehabilitation Medicine, Islamabad, Pakistan: lead

Study Sites (1)

National Institute of Rehabilitation Medicine (NIRM)

Islamabad, Federal Capital, 44000, Pakistan

RECRUITING

Related Publications (9)

• Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, Mulvihill B, Durkin MS, Fitzgerald RT, Maenner MJ, Patz JA, Yeargin-Allsopp M. Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the Autism and Developmental Disabilities Monitoring Network. Res Dev Disabil. 2011 Mar-Apr;32(2):462-9. doi: 10.1016/j.ridd.2010.12.042. Epub 2011 Jan 26.

  PMID: 21273041 BACKGROUND

• Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.

  PMID: 12600249 BACKGROUND

• Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9.

  PMID: 16437058 BACKGROUND

• Reddihough DS, Jiang B, Lanigan A, Reid SM, Walstab JE, Davis E. Social outcomes of young adults with cerebral palsy. J Intellect Dev Disabil. 2013 Sep;38(3):215-22. doi: 10.3109/13668250.2013.788690. Epub 2013 May 14.

  PMID: 23672634 BACKGROUND

• Hurvitz EA, Leonard C, Ayyangar R, Nelson VS. Complementary and alternative medicine use in families of children with cerebral palsy. Dev Med Child Neurol. 2003 Jun;45(6):364-70. doi: 10.1017/s0012162203000707.

  PMID: 12785436 BACKGROUND

• Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.

  PMID: 23962350 BACKGROUND

• 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: 31488980 BACKGROUND

• Novak I, Berry J. Home program intervention effectiveness evidence. Phys Occup Ther Pediatr. 2014 Nov;34(4):384-9. doi: 10.3109/01942638.2014.964020. Epub 2014 Oct 15. No abstract available.

  PMID: 25317927 BACKGROUND

• Mahmood Q, Habibullah S, Aurakzai HU. Effectiveness of simple and basic home-based exercise programs including pediatric massage executed by caregivers at their homes in the management of children with spastic cerebral palsy: A randomized controlled trial. J Pediatr Rehabil Med. 2024;17(1):97-106. doi: 10.3233/PRM-220135.

  PMID: 38427509 DERIVED

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic; Cerebral Palsy; Muscle Spasticity

Interventions

Medicine, Thai Traditional

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Qamar Mahmood

  HOD, Physiotherapy Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qamar Mahmood

CONTACT

Mahmood; qamarpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be kept blind about group allocation and identification of the participants before assessments at baseline, after 06 weeks and 12 weeks of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a RCT with two groups, RPT and Massage. Both groups will receive routine physical therapy (with addition of traditional massage in Massage group only) five days a week for a period of 12 weeks.

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 8, 2021
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 5, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)