NCT02838446

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

July 11, 2016

Last Update Submit

July 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Pain intensity

    8 weeks

  • Normal range of motion

    8 weeks

  • Grip Strength

    8 weeks

Study Arms (2)

Cognitive Therapy

EXPERIMENTAL

Graded motor imagery program was applied in only intervention group for 8 weeks.

Procedure: Cognitive Therapy

Control

ACTIVE COMPARATOR

Rehabilitation program applied in both groups for 8 weeks. Frequency of the treatment was 2 days in per week and its duration was approximately one hour in one session.

Procedure: Cognitive Therapy

Interventions

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

Also known as: Rehabilitation
Cognitive TherapyControl

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages between 18-65 years
  • diagnosed with DRFx which is extra-articular
  • managed with pins, internal fixation and/or cast

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist FracturesPain

Interventions

Cognitive Behavioral TherapyRehabilitation

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, Ass. Prof. Dr.

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 20, 2016

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations