Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture

Pain Clinical Trial

Official title:

Cognitive Therapy Model: Graded Motor Imagery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838446
• Other study ID #: GO 14/06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 11, 2016
• Last updated: July 15, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Hacettepe University
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was carried out on 36 patients. These patients were randomly assigned to two groups: classic treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week) physical therapy and rehabilitation intervention. Outcome measurements were based on upper extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale), range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation with goniometer), grip strength (standard grip strength with Jamar hydraulic hand dynamometer; lateral, palmar and pinch strength with pinch meter).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ages between 18-65 years

• diagnosed with DRFx which is extra-articular

• managed with pins, internal fixation and/or cast

Exclusion Criteria:

• unwilling or unable to participate

• intra-articular and instable fractures containing other part of the fractures

• fractures related with the malignancy and other neurologic diseases

• existing inflammatory joint condition,

• lack of cognitive function.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Pain
• Radius Fractures

Intervention

Procedure:
• Cognitive Therapy
Graded Motor Imagery has three stages: Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)

Locations

Country	Name	City	State
Turkey	Medipol University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Function and Symptoms	Disability of the Arm, Shoulder and Hand (DASH) questionnaire scores range from 0 to 100 with a higher score indicating higher degree of disability.	8 weeks	No
Secondary	Pain intensity	Visual Analog Scale (VAS) is used to evaluate pain intensity. The scale was consisted of a standard line labeled 0 on the left and 10 on the right. (0: no pain, 10: the worst pain).	8 weeks	No
Secondary	Normal range of motion	Active range of motions of wrist regarding flexion, extension, ulnar deviation, radial deviation, supination and pronation were evaluated with universal goniometer and recorded as degree.	8 weeks	No
Secondary	Grip Strength	Grip strength was measured in kilograms using a calibrated Jamar Hydraulic Hand Dynamometer with the elbow flexed to 90 degree.	8 weeks	No