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临床试验/CTRI/2025/08/093301
CTRI/2025/08/093301尚未招募3 期

Early Physical therapy intervention following acute knee joint bleed in persons with Haemophilia in resource limited settings.

Christian Medical College Vellore1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Knee Range of motion

研究概览

简要总结

Patients with acute knee joint bleed will be assessed for eligibility and included in the study after a written consent. They will be evaluated by the Principal Investigator (PI) for acute joint bleed symptoms. When the patient is clinically diagnosed with acute bleed, they will be given clotting factor replacement therapy following which patient will be sent for Ultrasound for confirmation of diagnosis. Following ultrasound, patients will be taught POLICE protocol (Protection, Optimal Loading, Ice, Compression and Elevation) and asked to come for therapy the following day. They will be evaluated for movement and pain in the affected joint every day. If the patient is able to move the joint in the mid-range without pain and the pain on Visual Analogue Score (VAS) has reduced to less than 4/10, they will be included for graded Physiotherapy (PT). The number of days taken to start the graded PT will be taken as optimal rest period following knee joint bleed.

Before starting graded PT, a baseline assessment will be done by the physical therapist (Outcome assessor) who will be blinded to the group allocation. The assessment will include measurement of pain using VAS scale, swelling using inch tape, knee flexion and extension range using a universal goniometer and an accelerometer, muscle power using Modified Oxford scale for manual muscle testing, joint health using Haemophilia Joint Health Score (HJHS) and ambulatory status using functional mobility scale. Following this, the patients will be randomized using sequentially numbered, opaque, sealed envelope (SNOSE) to two groups. Physical therapy intervention for the two groups will be given by the PI. The interventional group will receive Hold-Relax technique along with 2 weeks of graded PT. The control group will receive only 2 weeks of graded PT. Graded PT will include isometric exercises, multiangled isometrics, static stretching, concentric and eccentric exercises, closed and open kinematic chain exercises and progressive gait training.

At the end of 2 weeks, the outcomes will be re-assessed by the physical therapist (blinded outcome assessor). The data will be analyzed to find out if addition of Hold-relax technique to a 2 – week graded physiotherapy program helped in improving the joint range of motion when compared to the control group. A follow-up assessment will be done at 3 months to re-assess the outcomes and to find out if there were any re-bleeds. In addition, the correlation between clinical and ultrasound diagnosis of acute knee joint bleed; the impact of cryotherapy on pain and duration of rest period; and optimal time for rest following acute knee joint bleed will also be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • Severe Haemophilia A or B, Patients with a unilateral acute knee joint bleed.

排除标准

  • Haemophilia A and B with inhibitor Fixed flexion deformity in the knee joint before the bleed Previous surgeries including TKR, THR, osteotomies Muscle haematomas or other joint bleeds on the same lower limb.

结局指标

主要结局

Knee Range of motion

时间窗: Pre-bleed | Day of joint bleed | 14 days post- bleed | 3 month follow-up

次要结局

  • Muscle power – Modified Oxford scale for Manual Muscle(testing, Dynamometer.)

研究者

发起方
Christian Medical College Vellore
申办方类型
Other [Fluid Research Grant]
责任方
Principal Investigator
主要研究者

Merlyn R

Christian Medical College Vellore,

研究点 (1)

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