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Recruiting NCT05891704

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

No phase Interventional Multiple Injuries of Hand (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hand therapy Rehabilitation intervention program that incorporate cultural reference, Conventional Hand therapy Rehabilitation intervention program.
Who it may be relevant to
Registry conditions: Multiple Injuries of Hand (Disorder). Basic parameters: 16 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Palestinian Territories
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Hand therapy Rehabilitation intervention program that incorporate cultural reference
    The intervention will provide a conventional hand therapy rehabilitation intervention program that incorporates cultural reference based on Focused Acceptance and commitment Therapy ( FACT).
  • Procedure Conventional Hand therapy Rehabilitation intervention program
    The intervention will provide a conventional hand therapy rehabilitation intervention program

Primary outcome measures

  • 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. [Time frame: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).]
  • 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. [Time frame: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).]
  • 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. [Time frame: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).]
Secondary outcome measures (12)
  • Modified Hand Injury Scoring System (MHISS) (Campbell & Kay, 1996; Urso-Baiarda et al., 2008) [Time frame: Baseline Time (T1)]
  • Standard Hydraulic JAMAR dynamometer (Bellace, Healy, Besser, Byron, & Hohman, 2000), and Pinch Gauge (Radomski & Latham, 2008). A change is being assessed [Time frame: Baseline Time (T1), Discharge 4-6 weeks (T2).]
  • Semmes-Weinstein Monofilament Test(van Vliet, Novak, & Mackinnon, 1993). a change is being assessed [Time frame: Baseline Time (T1), Discharge 4-6 weeks (T2).]
  • Visual Analog Scale. A change is being assessed [Time frame: 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 [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline Time (T1), 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 [Time frame: Baseline Time (T1), 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 [Time frame: Baseline Time (T1), Discharge 4-6 weeks (T2), 3 months (T3), 6 months (T4) , 9 months (T5).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Palestinian Territories · 1 center
  • Arab American University — Jenin

Identifiers

NCT: NCT05891704 · Jumana Daibes

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗