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

T

Tel Aviv University

Status

Enrolling

Conditions

Multiple Injuries of Hand (Disorder)

Treatments

Procedure: Conventional Hand therapy Rehabilitation intervention program
Procedure: Hand therapy Rehabilitation intervention program that incorporate cultural reference

Study type

Interventional

Funder types

Other

Identifiers

NCT05891704
Jumana Daibes

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups

Intervention group
Experimental group
Description:
The Intervention Group (IG) will receive 12-16 meetings of the standard conventional hand-therapy program according to OT intervention protocols used for clients with HI. The IG will receive one hour of 2-3 sessions a week according to patient needs and convenience. In each treatment session, the participant will receive 30 minutes of preparatory activities and therapeutic exercise, 15 min of Occupation-Based Activities, and 15 min for the culturally adjusted intervention that will be based on Focused Acceptance and Commitment Therapy (FACT) with major emphasis on values. In IG Arabic cultural values will be considered in the entire therapy process, the participant will have a companion in the therapy session. The participants in IG will be provided with a home-therapy protocol, and will complete a home program that will be based on enhancement of work values. Checklist diary will be provided to participants
Treatment:
Procedure: Hand therapy Rehabilitation intervention program that incorporate cultural reference
Control group
Active Comparator group
Description:
The Control Group (CG) will follow the identical therapy protocol as the IG which will last for 45 minutes, with no culturally relevant interventions. In addition, each participant in the CG group will receive 15 minutes of free conversation with narrative feedback regarding the therapy, the challenges and opportunities in his daily life. Home-therapy protocol that will be based on conventional intervention will be provided.
Treatment:
Procedure: Conventional Hand therapy Rehabilitation intervention program

Trial contacts and locations

1

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Central trial contact

Jumana S Daibes, PhD. student; Navah Z Ratzon, Prof.

Data sourced from clinicaltrials.gov

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