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

NCT ID: NCT05891704

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-01-01

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.

Conditions

Multiple Injuries of Hand (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Hand therapy Rehabilitation intervention program that incorporate cultural reference

Intervention Type: PROCEDURE

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

Control group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Hand therapy Rehabilitation intervention program

Intervention Type: PROCEDURE

The intervention will provide a conventional hand therapy rehabilitation intervention program

Interventions

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).

Intervention Type: PROCEDURE

Conventional Hand therapy Rehabilitation intervention program

The intervention will provide a conventional hand therapy rehabilitation intervention program

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Navah Ratzon

Head of School of Health Profession

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Navah Z Ratzon, Professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

Arab American University

Jenin, , Palestinian Territories

Site Status: RECRUITING

Countries

Palestinian Territories

Central Contacts

Jumana S Daibes, PhD. student

Role: CONTACT

jumana.daibes@aaup.edu

00970599672878 ext. 1279

Navah Z Ratzon, Prof.

Role: CONTACT

navah@tauex.tau.ac.il

00972505468924

Facility Contacts

Amer Jaroushi, Master

Role: primary

amer.jaroshy@aaup.edu

042418888 ext. 1858

Alaa Bath, Master

Role: backup

alaa.bath@aaup.edu

042418888 ext. 1859

Other Identifiers

Jumana Daibes

Identifier Type: -

Identifier Source: org_study_id