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

Not Applicable

Completed

• Conditions: Haemophilic Arthropathy of Knee
• Interventions: Other: Standard exercise therapy; Other: Plyometric-based hydro-kinesio therapy

• Registration Number: NCT05947110
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2021-09-05
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-07
• Last Update Submitted: 2023-07-07
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard exercise therapy	Participants in this group received the standard exercise program.
Plyo-HKT group	Plyometric-based hydro-kinesio therapy	Participants in this group received the Plyo-HKT program

Primary Outcome Measures

Name	Time	Method
Postural control	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.
Pain intensity	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".
Muscle strength	2 months	Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.

Secondary Outcome Measures

Name	Time	Method
Functional independence	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.
Six-minute walk test	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.

Trial Locations

Locations (1)

Ragab K. Elnaggar; 🇸🇦 Al Kharj, Riyadh, Saudi Arabia