An interventional study of Experimental Group and Control Group in Distal Radius Fractures, sponsored by Hand Surgery Associates LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Hand Surgery Associates LLC · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 50 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with Hand Surgery Associates LLC as lead sponsor.
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Exclusion Criteria:
The experimental group will receive sensorimotor intervention and traditional hand therapy
Other: Experimental Group
Control Group will receive Hand Therapy only
Other: Control Group
Sensorimotor intervention, active range of motion, active assisted range of motion, strengthening
Active range of motion, active assisted range of motion and strengthening
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
Time frame: Baseline, 3 and 6 weeks
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
Time frame: Baseline, 3 and 6 weeks
Plan to share: No — Only the researchers identified will have access to the participant data. 2 of the 3 researchers identified will be collecting the data.
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