NCT07072416

Brief Summary

Cerebral palsy (CP) is a neurologic disorder that affects motor function, balance, and posture, and spastic hemiplegia is found in about one-third of persons with CP and often leads to devastating upper limb disability. Rehabilitation interventions such as aquatic therapy and mirror therapy are commonly utilized to improve motor function and functional independence. Water therapy takes advantage of water resistance and buoyancy to relax tightened muscles, promote gross motor function, and increase muscle endurance and strength with studies showing significant improvements in motor skills as well as a reduction in spasticity in CP children, especially hemiplegic children. Water therapy can also be more enjoyable and convenient for kids, but safety has to be considered. Mirror therapy does utilize visual feedback, but to cause the movement in the paralyzed limb, and can increase hand dexterity and grip strength by stimulating the neural pathways through the illusion of movement. Although aquatic therapy has shown well-defined advantages in motor functioning and muscle tone, comparison of the efficacy of aquatic exercises and mirror therapy for hand dexterity and grip strength in hemiplegic CP has been limited, and further studies are indicated to establish their relative merits and potential complementary uses.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 9, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

Aquatic Based ExercisesHemiplegic ChildHand DexterityMirror TherapyHand StrenghtCerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • Box and Block Test: It was used to assess gross manual dexterity

    The Box and Block Test (BBT) is a widely used test to evaluate gross manual dexterity by rehabilitation centers and occupational therapy clinics. The individual has to move as many blocks as possible from one of the compartments of a box to the other in a given time period, usually one minute, using one hand at a time. The BBT is valued for simplicity, ease of use, and strong reliability and validity across the lifespan, and in clinical populations like children, adults, and those with neurological or musculoskeletal disorder

    3 Months

  • Hand held dynamometer to assess hand grip strength.

    A popular, trustworthy, and legitimate tool for evaluating hand grip strength-a crucial sign of general muscle function and health-is a hand-held dynamometer.

    3 Months

Study Arms (3)

Group 1: Aquatic Therapy

EXPERIMENTAL

Children in Group A will receive aquatic based exercises and a designed physical therapy program

Other: Aquatic ExerciseOther: Designed physical therapy program.

Group 2: Mirror Therapy

EXPERIMENTAL

Group B will receive mirror therapy and a designed physical therapy program

Other: Mirror TherapyOther: Designed physical therapy program.

Group 3: Control Group

OTHER

Control Group (C) will receive a designed physical therapy program.

Other: Designed physical therapy program.

Interventions

Aquatic exercise or hydrotherapy, involving the performance of physical exercise in water, has been determined to have an assortment of beneficial health impacts on healthy individuals and those with chronic diseases. Aquatic exercise has been determined to enhance strength, balance, flexibility, and the quality of life, particularly among groups like postmenopausal women, patients with osteoarthritis, Parkinson's disease, and type 2 diabetes

Group 1: Aquatic Therapy

Mirror therapy is a type of rehabilitation where visual feedback is employed to induce movement and recovery in an affected limb by asking the patients to observe the reflection of their healthy limb in a mirror, giving the illusion that both limbs are moving normally.

Group 2: Mirror Therapy

The program will start with 10 minutes of poolside exercises including warming up, active range of motion and stretching followed by 20 minutes of aquatic exercise in the pool. The pool session consists of 20 minutes of active range of motion, stretching and strengthening exercises

Group 1: Aquatic TherapyGroup 2: Mirror TherapyGroup 3: Control Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with Hemiplegic cerebral palsy
  • Children with mild to moderate spasticity of wrist muscles spasticity will range between (0-4) score according to Modified Ashworth Scale.
  • Children will be able to follow the instructions.
  • Children without any genetic disorders.

You may not qualify if:

  • Cognitive impairment.
  • Unilateral neglect disorders.
  • Orthopedic dysfunction.
  • Visual impairment.
  • Verbal impairment.
  • Open wound or infection
  • Fixed contractures.
  • Previous limb surgeries within 6 months.
  • Resting angina.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhur Medical National Institute Hospital

Damanhur, Beheira, 5844152, Egypt

Location

Related Publications (6)

  • Adar S, Dundar U, Demirdal US, Ulasli AM, Toktas H, Solak O. The effect of aquatic exercise on spasticity, quality of life, and motor function in cerebral palsy. Turk J Phys Med Rehabil. 2017 Aug 14;63(3):239-248. doi: 10.5606/tftrd.2017.280. eCollection 2017 Jun.

    PMID: 31453460BACKGROUND
  • Roostaei M, Baharlouei H, Azadi H, Fragala-Pinkham MA. Effects of Aquatic Intervention on Gross Motor Skills in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):496-515. doi: 10.1080/01942638.2016.1247938. Epub 2016 Dec 14.

    PMID: 27967298BACKGROUND
  • El-Shamy SM. Effects of Antigravity Treadmill Training on Gait, Balance, and Fall Risk in Children With Diplegic Cerebral Palsy. Am J Phys Med Rehabil. 2017 Nov;96(11):809-815. doi: 10.1097/PHM.0000000000000752.

    PMID: 28410250BACKGROUND
  • Lai CJ, Liu WY, Yang TF, Chen CL, Wu CY, Chan RC. Pediatric aquatic therapy on motor function and enjoyment in children diagnosed with cerebral palsy of various motor severities. J Child Neurol. 2015 Feb;30(2):200-8. doi: 10.1177/0883073814535491. Epub 2014 Jun 5.

    PMID: 24907137BACKGROUND
  • Ryu K, Ali A, Kwon M, Lee C, Kim Y, Lee G, Kim J. Effects of assisted aquatic movement and horseback riding therapies on emotion and brain activation in patients with cerebral palsy. J Phys Ther Sci. 2016 Dec;28(12):3283-3287. doi: 10.1589/jpts.28.3283. Epub 2016 Dec 27.

    PMID: 28174435BACKGROUND
  • Stavsky M, Mor O, Mastrolia SA, Greenbaum S, Than NG, Erez O. Cerebral Palsy-Trends in Epidemiology and Recent Development in Prenatal Mechanisms of Disease, Treatment, and Prevention. Front Pediatr. 2017 Feb 13;5:21. doi: 10.3389/fped.2017.00021. eCollection 2017.

    PMID: 28243583BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHemiplegiaParesis

Interventions

Aquatic TherapyMirror Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding to the assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

May 1, 2025

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

It will provided only upon reasonable request

Locations