Plyometric-Based Hydro-Kinesio Therapy in Children With Hemophilic Arthropathy

July 7, 2023 updated by: Ragab Kamal Elnaggar, Cairo University

How Effective is the Plyometric-based Hydro-kinesio Therapy for Pain, Muscle Strength, Postural Control, and Functional Performance in Children With Hemophilic Knee Arthropathy?

This study was designed to assess the effect of an 8-week plyometric-based hydro-kinesio therapy (Plyo-HKT) on pain, muscle strength, postural control, and functional performance in a convenience sample of children with hemophilic knee arthropathy (HKA). Forty-eight patients with HKA were randomly allocated to the Plyo-HKT group (n = 24, received the plyometric-based hydro-kinesio therapy program, twice/week, over 8 weeks) or the control group (n = 24, received standard exercise program). Both groups were assessed for pain, muscle strength, postural control, and functional performance pre and post-treatment.

Study Overview

Detailed Description

Forty-eight boys with moderate hemophilia-A were recruited from the hematology clinics of three large referral hospitals in Riyadh, Saudi Arabia. The study included patients who were 8-16 years old, had factor VIII replacement prophylaxis, were clinically-stable cases, had unilateral knee hemarthrosis, had grade II or III knee arthropathy, had muscle strength of grade three, and if they were able to walk independently. Patients who had enduring disabling pain, fixed deformities, a history of musculoskeletal surgery, visual and/or vestibular deficits, or bleeding episodes within two weeks before enrollment were excluded.

Outcome measures

Pain: Pain during rest and/or movement was assessed using the Numerical Pain Rating Scale.

Muscle strength: The peak concentric torque of the quadriceps and hamstring muscles was measured through an Isokinetic Dynamometer.

Postural control: The directional dynamic limit of stability (forward, backward, affected, and non-affected) and overall limit of stability were assessed using the Biodex balance system.

Functional performance: The extent of functional capacity was assessed through the functional independence score in hemophilia and the six-minute walk test.

Interventions

The Plyo-HKT group received the Plyo-HKT program, 45 minutes per session, two times a week for 8 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Plyo-HKT program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The Plyo-HKT included a warm-up for 10 minutes and a cool-down for 5 minutes. The control group received the standard exercise program, 45 minutes per session, two times a week for 8 consecutive weeks. The program consisted of flexibility exercise, strength training, weight-bearing, proprioceptive training, and free treadmill walking or cycle ergometry.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Riyadh
      • Al Kharj, Riyadh, Saudi Arabia
        • Ragab K. Elnaggar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eight and 16 years.
  • Had factor VIII replacement prophylaxis.
  • Clinically-stable.
  • Unilateral knee involvement.
  • Knee arthropathy of grade II or III per the Arnold-Hilgartner radiographic classification.
  • Muscle strength of grade 3 in lower limb muscles.
  • Use of no pain medication for one month prior to enrollment.
  • Walking independently.

Exclusion Criteria:

  • Enduring disabling pain
  • Fixed deformities.
  • History of musculoskeletal surgery.
  • Visual or vestibular deficits.
  • Engagement in regular exercises.
  • Bleeding episodes within two weeks prior to enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Participants in this group received the standard exercise program.
The program encompassed the standard exercises for patients with JIA (aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises). The training was conducted for 45 minutes, two times a week for 8 successive weeks.
Experimental: Plyo-HKT group
Participants in this group received the Plyo-HKT program
The plyometric-based hydro-kinesio therapy was conducted for 45 minutes, twice weekly, for 8 successive weeks. The training was geared toward the lower body and was conducted under the close supervision of a licensed pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 2 months
Participants reported how much they feel pain during rest and/or movement on the 0-10 Numerical Pain Rating Scale, where 0 represents "no pain" and 10 indicates the "worst possible pain".
2 months
Muscle strength
Time Frame: 2 months
Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.
2 months
Postural control
Time Frame: 2 months
The capacity to control and move the center of gravity in various directions across the base of support was assessed utilizing the Biodex balance system. Values are expressed as accuracy % and higher scores mean better balance capability.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-minute walk test
Time Frame: 2 months
The six-minute walk test measured the walking distance that children were able to cover across a 30-m walkway with a self-determined walking pace over six minutes. A longer distance indicates a better performance.
2 months
Functional independence
Time Frame: 2 months
The functional independence was assessed using the Functional Independence Score in Hemophilia. The test includes an assessment of eight activities, divided into three categories (selfcare, transfer, and mobility). Each activity is rated on a 1-4 scale, where 1 indicates that participant was unable to execute the action or requires full support and 4 indicates being able to do the task without any difficulties. The maximum score is 32, which denotes the highest degree of independence.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ragab K Elnaggar, PhD, Prince Sattam bin Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2021

Primary Completion (Actual)

January 26, 2023

Study Completion (Actual)

January 26, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHPT/0021/0033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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