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Completed

NCT Number: NCT05947110

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

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Key information

Age range

8 year–16 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plyometric-based hydro-kinesio therapy

Other

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.

Standard Exercise Therapy

Other

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.

Primary outcomes

  1. 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. 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.

  3. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.