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

Primary Purpose

Haemophilic Arthropathy of Knee

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Plyometric-based hydro-kinesio therapy
Standard exercise therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemophilic Arthropathy of Knee

Eligibility Criteria

8 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ragab K. Elnaggar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plyo-HKT group

Control group

Arm Description

Participants in this group received the Plyo-HKT program

Participants in this group received the standard exercise program.

Outcomes

Primary Outcome Measures

Pain intensity
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
Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.
Postural control
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 Outcome Measures

Functional independence
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
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.

Full Information

First Posted
July 7, 2023
Last Updated
July 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05947110
Brief Title
Plyometric-Based Hydro-Kinesio Therapy in Children With Hemophilic Arthropathy
Official 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?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2021 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilic Arthropathy of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plyo-HKT group
Arm Type
Experimental
Arm Description
Participants in this group received the Plyo-HKT program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group received the standard exercise program.
Intervention Type
Other
Intervention Name(s)
Plyometric-based hydro-kinesio therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard exercise therapy
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Description
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".
Time Frame
2 months
Title
Muscle strength
Description
Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.
Time Frame
2 months
Title
Postural control
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Functional independence
Description
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.
Time Frame
2 months
Title
Six-minute walk test
Description
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.
Time Frame
2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

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

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