Haemophilic Arthropathy of KneeNCT05947110
Plyometric-Based Hydro-Kinesio Therapy in Children With Hemophilic Arthropathy
A study testing Plyometric-based hydro-kinesio therapy and Standard exercise therapy in people with Haemophilic Arthropathy of Knee, run by Cairo University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 16 years, men only
- Conditions the study is for
- Haemophilic Arthropathy of Knee
- What is being tested?
- Plyometric-based hydro-kinesio therapy and Standard exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Sep 2021to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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.
- Conditions
- Haemophilic Arthropathy of Knee
- Being tested
- Plyometric-based hydro-kinesio therapy, Standard exercise therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric-based hydro-kinesio therapyOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Plyo-HKT group | Experimental | Participants in this group received the Plyo-HKT program Receives: Other: Plyometric-based hydro-kinesio therapy |
| Control group | Active comparator | Participants in this group received the standard exercise program. Receives: Other: Standard exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 2 months
Muscle strength
Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.
Measured: 2 months
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.
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start5 Sep 2021
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilic Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947110
- Sponsor's protocol ID
- RHPT/0021/0033
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05947110
- Acronym / sponsor ID
- RHPT/0021/0033
- Conditions
- Haemophilic Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Plyo-HKT group | Experimental | Other: Plyometric-based hydro-kinesio therapyParticipants in this group received the Plyo-HKT program |
| Control group | Active comparator | Other: Standard exercise therapyParticipants in this group received the standard exercise program. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- Enduring disabling pain
- Fixed deformities.
- History of musculoskeletal surgery.
- Visual or vestibular deficits.
- Engagement in regular exercises.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plyometric-based hydro-kinesio therapyThe 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. | Other | Plyo-HKT group |
| Standard exercise therapyThe 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. | Other | Control group |
Primary outcome
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".
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.
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 secondary outcomes
Functional independence
Time frame: 2 months
Six-minute walk test
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric-based hydro-kinesio therapy and Standard exercise therapy in people with Haemophilic Arthropathy of Knee, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.