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临床试验/NCT05891704
NCT05891704尚未招募不适用

The Efficacy of Hand Injuries Rehabilitation Intervention Program That Incorporated Ethnic and Cultural Reference

Tel Aviv University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
A change in a baseline evaluation of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH) to discharge and from therapy and the change at three, six, and nine months are being assessed.

研究概览

简要总结

The study has three main phases. The first phase included A. Adjustment of research tools. Phase B. will examine the efficacy of the cultural intervention. Phase C. Follow-up study will be conducted after three, six, and nine months.

详细描述

Trauma to the hand is a common and potentially serious injury. Work is central to most adults' occupational identity and is, therefore, a key focus for occupational therapy (OT) intervention. There is substantial evidence that supports the use of OT to target work and its positive influence on Return to Work (RTW) after injury. OT literature shows a shift regarding the awareness of cultural concerns and the broader context in which OT operates. There is currently no high-quality evidence to support the efficacy of rehabilitation programs that enhance RTW in workers with Hand Injury (HI). Aims: The proposed study aims to examine the efficacy of a hand-injuries rehabilitation intervention program that incorporates ethnic-cultural references versus conventional intervention programs. Objective and subjective measures will be used to evaluate personal and environmental aspects and address their influence on readiness to RTW, time to RTW, and, for those who will RTW, employer satisfaction about the worker's performance. Method: The Study has Three Phases: 1. A cross-sectional study to assess internal consistency and test-retest reliability and construct and concurrent validity of the study questionnaires. Study participants: Convenient sample of 60 healthy and 30 HI Palestinian participants will be recruited. Tools: Arabic Work Value Questionnaire (A-Wval), the Arabic Employment Barrier Questionnaire (A-EBQ), the Arabic Return to Work Self-Efficacy-19 (A-RTWSE-19) questionnaire, the Arabic Readiness for Return-To-Work (A-RRTW), Arabic Return-to-Work status questionnaire (A-RTWS), and Arabic Work Behavior Inventory (A-WBI). 2. Matched paired trial design method will be conducted to assess the efficacy of a hand-injuries rehabilitation intervention program that incorporates ethnic-cultural reference versus conventional intervention programs that will improve the participants' functioning in Vocational Rehabilitation(VR) and enhance Time of Return to Work (TRTW). Study participants: 100 HI participants will be first matched in pairs according to gender, age (interval of 5 years), and severity of the injury. Then, each member of a pair will be randomly assigned to the intervention group (IG) and Control Group (CG). 3. Follow-up study after three, six, and nine months.

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
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will include people after acute traumatic injuries below the elbow, 16-65 years old, who were employed or functioning as active housewives prior to the injury. All participants will be Palestinian Arabs living in the West Bank

排除标准

  • People with drug/alcohol abuse, central nervous lesions, psychiatric, cognitive or developmental disorder, people with bilateral injury, hand burns, rheumatoid arthritis, osteoarthritis, brachial plexus lesion, shoulder or elbow problems, complex regional pain syndrome, or any surgery during the study period. People with non-traumatic hand injuries (tendonitis, carpal tunnel syndrome, trigger finger, De Quervain's disease, and Mallet finger) will not be included

结局指标

主要结局

A change in a baseline evaluation of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH) to discharge and from therapy and the change at three, six, and nine months are being assessed.

时间窗: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).

The self-reported upper extremity outcome measure for assessing physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb, whose primary language is Arabic.

A change in baseline of Time to Return to Work (T-RTW) to discharge from therapy and the change at three, six, and nine months are being assessed.

时间窗: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).

the time to return to work since onset

A change in baseline Work Rehabilitation Questionnaire (WORQ) (Finger, Escorpizo, Bostan, & De Bie, 2014) to discharge from therapy and at three, six, and nine months follow-up is being assessed.

时间窗: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).

ICF-based questionnaire to evaluate functioning in Vocational Rehabilitation (VR), The WORQ consists of two sections. Section 1 contains 17 socio demographic and work-related items, the work-related questions include profession, work status, work demands, VR interventions, and the amount of support received by family, employer, and labor and employment services while section two contains 40 items on functioning (18 body functions and 22 activities and participation items). WORQ captures the extent of functioning problems for all 40 items with a numeric rating scale of 0 to 10

次要结局

  • Standard Hydraulic JAMAR dynamometer (Bellace, Healy, Besser, Byron, & Hohman, 2000), and Pinch Gauge (Radomski & Latham, 2008). A change is being assessed(Baseline Time (T1), Discharge 4-6 weeks (T2).)
  • Semmes-Weinstein Monofilament Test(van Vliet, Novak, & Mackinnon, 1993). a change is being assessed(Baseline Time (T1), Discharge 4-6 weeks (T2).)
  • Modified Hand Injury Scoring System (MHISS) (Campbell & Kay, 1996; Urso-Baiarda et al., 2008)(Baseline Time (T1))
  • Visual Analog Scale. A change is being assessed(Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • Post Traumatic Growth Inventory (PTGI) (Tedeschi & Calhoun, 1996). A change is being assessed(Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • The Employment Barriers Questionnaire (EBQ) (Ratzon, Starik, Huber, & Zeilig, 2019). A change is being assessed.(Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • Return-to-work status questionnaire (Boyle, Cassidy, & Côté, 2019). A change is being assessed(Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • The 12-item WHODAS 2.0 questionnaire - Arabic(Badr and Abd El Aziz 2007; Üstün et al. 2010). A change is being assessed(Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • Work Behavior inventory (G. Bryson, M. D. Bell, P. Lysaker, & W. J. P. R. J. Zito, 1997b). A change is being assessed(Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • The Medical Outcome Study Short Form 12 (Ware Jr, Kosinski, & Keller, 1996). A change is being assessed(Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • Return -to-work self-efficacy scale-19 (RTWSE-19). (Shaw, Reme, Linton, Huang, & Pransky, 2011). Arabic version(Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • The Readiness for Return-to-Work (RRTW) scale (Franche, Corbière, Lee, Breslin, & Hepburn, 2007). A change is being assessed(Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)
  • Single Subject Job Satisfaction Scale (Dolbier et al. 2005). A change is being assessed(Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Navah Ratzon

Head of School of Health Profession

Tel Aviv University

研究点 (1)

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