Trial Outcomes & Findings for Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures (NCT NCT00438750)

NCT ID: NCT00438750

Last Updated: 2012-06-08

Results Overview

Mean arc of wrist flexion and extension six months after surgery. Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2012-06-08

Participant Flow

Participant milestones

Measure	Independent Exercise Cohort Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Overall Study STARTED	48	46
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures

Baseline characteristics by cohort

Measure	Independent Exercise Cohort n=48 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=46 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	37 Participants n=7 Participants	81 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Age Continuous	49 years STANDARD_DEVIATION 15 • n=5 Participants	51 years STANDARD_DEVIATION 15 • n=7 Participants	50 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	46 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Mean arc of wrist flexion and extension six months after surgery.

Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Range of Motion in Degrees of the Wrists	129 Degrees Standard Deviation 22.6	118 Degrees Standard Deviation 17.7

SECONDARY outcome

Timeframe: 6 months

The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.

Mean and standard deviations are identical for both arms.

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	7.8 units on a scale Standard Deviation 7.8	6.7 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 6 months

A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
10-point Ordinal Pain Scale	0.8 units on a scale Standard Deviation 1.4	1.0 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 6 months

Pinch strength measured with the B&L pinch gauge.

B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Pinch Strength	15 Pounds (lbs) Standard Deviation 4.3	17 Pounds (lbs) Standard Deviation 8.6

SECONDARY outcome

Timeframe: 6 months

An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Gartland and Werley Score	0.9 units on a scale Standard Deviation 1.2	1.1 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 6 months

A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Mayo Wrist Score	83.4 units on a scale Standard Deviation 12.7	79.0 units on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: 6 months

Measured with use of a grip meter as the average of three attempts.

Outcome measures

Measure	Independent Exercise Cohort n=39 Participants Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=37 Participants Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Grip Strength	57 Pounds (lbs) Standard Deviation 18.5	51 Pounds (lbs) Standard Deviation 17.9

Adverse Events

Independent Exercise Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Occupational Therapy Cohort

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Independent Exercise Cohort n=48 participants at risk Subjects who learn their therapy exercises from the surgeon and practice them independently at home.	Occupational Therapy Cohort n=46 participants at risk Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Musculoskeletal and connective tissue disorders Extensor pollicis longus tendon rupture	0.00% 0/48	2.2% 1/46 • Number of events 1
Musculoskeletal and connective tissue disorders Loosening and prominence of a distal (periarticular) screw	0.00% 0/48	2.2% 1/46 • Number of events 1

Additional Information

David Ring, MD, PhD

Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital

Phone: 617-724-3953

Email: dring@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place