Compression Gloves for Distal Radius Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength.

Compression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF).

This study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF.

Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture.

ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures):

S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4).

S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of the Dart-throwing Motion Plane in Hand Therapy After Distal Radius Fractures

NCT03918174

Distal Radius Fracture

COMPLETED NA

Supervised vs. Home-Based vs. No Therapy for Uncomplicated Distal Radius Fracture in Younger Adults

NCT06913894

Distal Radius Fractures

RECRUITING NA

Closed Kinetic Chain Exercise Versus Russian Current Stimulation in Rehabilitation of Colles' Fracture.

NCT02494011

Distal Radius Fracture

COMPLETED NA

Association Between Hand-Eye Coordination and Handgrip Strength in Children Post-Healing of DRGF

NCT07037355

Radius Fractures

ACTIVE_NOT_RECRUITING

Patients With Distal Radius Fracture

NCT04071002

Physical Disability

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Radius Fractures Fracture of Lower End of Radius Colles' Fracture Smith's Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Made-to-Measure Compression Gloves

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

Group Type EXPERIMENTAL

Made-to-Measure Compression Gloves

Intervention Type DEVICE

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

Control

Routine follow up and treatment

Group Type OTHER

Routine follow up and treatment

Intervention Type OTHER

Control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Made-to-Measure Compression Gloves

Made-to-Measure Compression Gloves in addition to routine follow up and treatment.

Intervention Type DEVICE

Routine follow up and treatment

Control

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.
2. Patients who demonstrate at enrolment at least two of the following:

* Pain,
* limited range of motion of the fingers and the wrist,
* limited strength (weakness of the hand/fingers),
* swelling /edema,
* Limited hand functions during performance of Activities of Daily Living (ADL).

Exclusion Criteria

* Neuropathy
* Peripheral vascular disease
* End stage renal disease
* Previous impairment of fingers/wrist range of motion.
* Previous Lymphedema of the injured hand
* Receiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids).
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No