Impact of Early ADL Participation on Outcomes Post DRF

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorge Washington University

About this trial

This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated conservatively in a cast. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while in a cast and cast care. The control group will watch a video on cast care and be given a handout on cast care. Outcome measures will be taken at initial evaluation between 0-3 weeks, at 6 weeks, at 9 weeks, and at 3 months. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ADL/Cast Care instruction

    Behavioral

    Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated in a cast and cast care. Participants in the experimental group will also receive a handout on ADL participation and cast care.

  • Cast Care Instruction

    Behavioral

    Participants in the control group will watch a video instructing them on cast care. Participants in the control group will receive a handout on cast care.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: ADL video/Cast CareExperimental treatment 2 interventions
Group B: Cast Care VideoActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Michigan Hand Questionnaire

Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

Time frame
baseline
2

Michigan Hand Questionnaire

Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

Time frame
6 weeks
3

Michigan Hand Questionnaire

Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

Time frame
9 weeks
4

Michigan Hand Questionnaire

Patient reported outcome measure for function, min value-0 max value-100 , higher score is best possible ability

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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George Washington University

Lead sponsor

American Hand Therapy Foundation

Collaborator