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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06299228
Other study ID # HSA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date April 2025

Study information

Verified date April 2024
Source Hand Surgery Associates LLC
Contact Nancy Naughton, OTD
Phone 5707808681
Email nancynaughton10@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.


Description:

The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study. The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Distal radius fracture with volar plate fixation - Understand English - 18 years or older - Available to attend skilled occupational therapy visits a minimum of 1x per week. Exclusion Criteria: - Prior surgery to the involved wrist/hand - Cognitive impairment - Distal radius fracture managed by casting or by another means of fixation

Study Design


Intervention

Other:
Experimental Group
Sensorimotor intervention, active range of motion, active assisted range of motion, strengthening
Control Group
Active range of motion, active assisted range of motion and strengthening

Locations

Country Name City State
United States Hand Surgery Associates Olyphant Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Hand Surgery Associates LLC Orthopaedic Specialty Group PC, Fairfield, Touro University Nevada

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Active Joint Position Sense (AJPS) Range of motion measurement for the wrist, the measurements are recorded in degress of motion and the greater the number of degrees is reflective of greater sensorimotor deficit Baseline, 3 and 6 weeks
Secondary Patient Rated Wrist and Hand Evaluation Patient reported outcome measurement with a 0-100 range, 0 indicating no functional deficit and 100 indicating the worst functional scale Baseline, 3 and 6 weeks
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