Clinical trial NCT05891704: The Efficacy of Hand Injuries Rehabilitation Intervention Program That Incorporated Ethnic and Cultural Reference
Official title: The Efficacy of Hand Injuries Rehabilitation Intervention Program That Incorporated Ethnic and Cultural Reference
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Injuries of Hand (Disorder)
Keywords: Hand Injury, Values, Culture, ACT, Hand Injury Intervention
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: 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

Exclusion Criteria: 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

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