Impact of Early ADL Education on Outcomes Post DRF ORIF

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-110
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 with surgical intervention of open reduction and internal fixation. 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 recovering from surgery and postoperative instructions. The control group will watch a video on wound care and be given a handout on postoperative instructions. Outcome measures will be taken at initial evaluation between 1-2 weeks post surgery, at 5-7 weeks post surgery, at 8-10 weeks, and at 12-14 weeks. 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/Postoperative Instruction

    Behavioral

    This is an education video which includes demonstration of simple ADL tasks that the participant can do at home after surgery. Handout includes the same information and a QR code to watch the video.

  • Postoperative Instruction

    Behavioral

    This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: ADL/Postoperative InstructionExperimental treatment 2 interventions
Group B: Postoperative InstructionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Michigan Hand Questionnaire

Patient reported outcome measure for function

Time frame
baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks

Secondary outcomes

1

Visual Analog Scale

patient reported outcome measure for pain intensity

Time frame
baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
2

Tampa Scale of Kinesiophobia

patient reported outcome measure for fear of movement

Time frame
baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
3

Range of Motion of digits

distance from digits to distal palmar crease in cm

Time frame
5-7 weeks, 8-10 weeks, 12-14 weeks
4

Grip and Pinch Strength

Jamar grip gauge testing and pinchmeter gauge testing for strength

Time frame
8-10 weeks, 12-14 weeks

Other outcomes

Sponsors and contacts

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