Trial Outcomes & Findings for Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy (NCT NCT02165462)

Results Overview

Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

Screening visit

Results posted on

2016-07-28

Participant Flow

Patients with haemophilia

Participant milestones

Participant milestones
Measure	Patients With Haemophilia Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Age, Continuous	32.47 years STANDARD_DEVIATION 7.82 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Spain	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Screening visit

Population: Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "\[100x (bilateral) / (right unilateral + left unilateral)\] - 100"

Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Bilateral Index of Maximal Peak Force	-40.86 percentage Standard Deviation 4.24

PRIMARY outcome

Timeframe: Screening visit

Population: Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "\[100x (bilateral) / (right unilateral + left unilateral)\] - 100"

Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Bilateral Index of Rate of Development During the Preparation Phase	31.34 percentage Standard Deviation 56.42

PRIMARY outcome

Timeframe: Screening visit

Population: Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "\[100x (bilateral) / (right unilateral + left unilateral)\] - 100"

Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Bilateral Index of Rate of Development During the Acceleration Phase	20.05 percentage Standard Deviation 38.20

PRIMARY outcome

Timeframe: Screening visit

Population: The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value)

Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Maximal Peak Force	15.67 N/kg Standard Deviation 1.36

PRIMARY outcome

Timeframe: Screening visit

Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Rate of Development During the Preparation Phase	6190.86 N/s Standard Deviation 2818.36

PRIMARY outcome

Timeframe: Screening visit

Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage). The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Change of Joint Condition Based on Clinical Assessment Right knee	4.88 Units on a scale (range 0-24) Standard Deviation 4.076
Change of Joint Condition Based on Clinical Assessment Left knee	3.00 Units on a scale (range 0-24) Standard Deviation 2.398
Change of Joint Condition Based on Clinical Assessment Right ankle	5.82 Units on a scale (range 0-24) Standard Deviation 3.575
Change of Joint Condition Based on Clinical Assessment Left ankle	6.35 Units on a scale (range 0-24) Standard Deviation 4.527

PRIMARY outcome

Timeframe: Screening visit

Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Rate of Development During the Acceleration Phase	8945.25 N/s Standard Deviation 2807.85

PRIMARY outcome

Timeframe: Screening visit

Population: The maximum speed (Vmax) was calculated as the maximum value of the first integral of the force-time curve for bilateral contractions, left-sided and right-sided

Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Assessment of Maximal Velocity of Movement	0.48 m/s Standard Deviation 0.11

SECONDARY outcome

Timeframe: Screening visit

The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Weight of the Patients With Haemophilia	73.48 Kg Standard Deviation 15.43

SECONDARY outcome

Timeframe: Screening visit

Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) Haemophilia A	15 participants
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) Haemophilia B	2 participants
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) Severe haemophilia	7 participants
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) Moderate haemophilia	5 participants
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) Mild haemophilia	5 participants
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) Prophylaxis treatment	8 participants
Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) On demand treatment	9 participants

SECONDARY outcome

Timeframe: Screening visit

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Joint Bleeding Before the Assessment	7 participants

SECONDARY outcome

Timeframe: Screening visit

The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Height of the Patients With Haemophilia	176.53 cm Standard Deviation 6.82

SECONDARY outcome

Timeframe: Screening visit

The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Body Mass Index of Patients With Haemophilia	23.36 kg/m2 Standard Deviation 4.48

SECONDARY outcome

Timeframe: Screening visit

Outcome measures

Outcome measures
Measure	Patients With Haemophilia n=17 Participants Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Age of Patients With Haemophilia	32.47 years Standard Deviation 7.82

Adverse Events

Patients With Haemophilia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rubén Cuesta-Barriuso, PhD

Universidad Católica San Antonio de Murcia

Phone: +34 913146508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place