A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total active motion (TAM)
研究概览
简要总结
a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand
详细描述
a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature.
Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females
- •between 25-50 years
- •Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit
- •the case should be recent (2-3 days post-surgical)
排除标准
- •age below 25 or above 50
- •a systemic disease affecting hand joints such as rheumatic arthritis
- •thumb flexor tendon repair will be excluded
- •chronic cases
- •concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss
研究组 & 干预措施
Early passive mobilization group
The modified Kleinert protocol will be used as an EPM procedure. Within 3 to 5 days following surgery, the affected hand will be placed inside the dorsal slab Kleinert splint with the wrist in 30-40 flexion; metacarpophalangeal joint (MP) in 60-70-degree flexion; PIP and DIP joints in extension. Rubber band traction will be directed to the fingernail from the wrist, with a palmar pulley system. All patients will perform passive flexion and active extension exercises with an active hold for 2-3 seconds 10 times per hour. Traction will be removed at the end of 3rd week and very gentle active flexion will start at the 4th week. The splint will be removed in the 5th-6th weeks. Blocking exercises will be started at 7th-8th weeks and resisted exercises will be started after the 8th week with the full function permitted by week 12th week .
干预措施: Early passive mobilization (Other)
Controlled active motion group
A modified CAM protocol will be used. Exercises will be performed hourly for 10 repetitions in the form of passive flexion and active extension exercises with an active hold of the fingers in the flexed position for 2-3 seconds.
干预措施: Controlled active motion (Other)
结局指标
主要结局
Total active motion (TAM)
时间窗: after the 12th week of intervention
This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" This formula determined the percentage of recovery of TAM. The results of TAM (%) were classified in four categories: "Excellent, good, fair, and poor"
handgrip strength
时间窗: after the 12th week of intervention
Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.
Functional disability
时间窗: after the 12th week of intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
Total active motion (TAM)
时间窗: at baseline
Active range of motion in proximal interphalangeal joint (PIP) and the distal interphalangeal joint (DIP) of the injured digits will be measured by manual hand goniometry. Outcome will be expressed by Strickland formula. TAM (%) = (Active flexion of PIP+DIP) - Extension Lag of both joints/175× 100 This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor"
handgrip strength
时间窗: baseline
Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.
Functional disability
时间窗: at baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
次要结局
未报告次要终点
研究者
Hisham Mohamed Hussein
principal investigator
University of Hail