NCT06215872

Brief Summary

When determining the treatment method to be applied in distal radius fracture (DRF), in addition to clinical and radiological evaluation, the patient's age, physical activity level, cognitive status, severity of trauma, mechanism of injury and type of fracture are important factors in the treatment plan. Clinical studies show that physiotherapy is useful in improving the limitation of movement and pain in DRF. It shows that the active movement level is increased by decreasing the level. Rehabilitation after surgery proceeds similarly to conservative treatment. When exercise approaches in the literature are examined, it is seen that specific exercises for the wrist and forearm are recommended for treatment, but it has been reported that there are not enough studies to constitute evidence value. For decades, the skeletal muscles of the human body have been characterized as independent structures. However, recent research supports the "single muscle theory", contrary to this classical view. According to this theory, the fascia tissue that covers the entire body connects the muscles to each other in the form of chains, and the muscles in the chain work together in performing functional movements. These chains are called myofascial chains. Fascia tissue that creates all these connections; It consists of tightly arranged connective tissue and is structurally similar to tendons and ligaments. It surrounds organs, muscles, vessels and nerves, connects tissues and allows them to slide and move over each other. Past histological studies have reported that there are also contractile cells in the fascia structure. Although there are problems in rehabilitation after DRF that go beyond a single segment and affect the whole body; There is no study in the literature that uses the myofascial chain exercises approach in the treatment of these problems. In the light of all this information, the thesis study aims to ensure the active participation of the upper body muscles in the rehabilitation process with the DRUK program planned with myofascial chain exercises and in this way to improve the functional level obtained as a result of rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

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

June 2, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

2.5 years

First QC Date

December 29, 2023

Last Update Submit

January 10, 2024

Conditions

Keywords

Tele-HealthExercisePhysical Therapy And RehabilitationDistal Radius Fractures

Outcome Measures

Primary Outcomes (1)

  • Quick DASH (The Disabilities of the Arm, Shoulder and Hand)

    Quick-DASH is an 11-item questionnaire that questions a person's limitations in upper extremity problems.

    Pre treatment and end of study (4 weeks after from first assessment)

Secondary Outcomes (7)

  • The Visual Analogue Scale (VAS)

    Pre treatment and end of study (4 weeks after from first assessment)

  • Hand Functional Index (HFI)

    Pre treatment and end of study (4 weeks after from first assessment)

  • Michigan Hand Outcomes Questionnaire (MHQ)

    Pre treatment and end of study (4 weeks after from first assessment)

  • Joint Range of Motion Measurement Test With Goniometer

    Pre treatment and end of study (4 weeks after from first assessment)

  • Hand Grip Strength Measurement Test With Hand Dynamometer

    Pre treatment and end of study (4 weeks after from first assessment)

  • +2 more secondary outcomes

Study Arms (3)

Upper Extremity Exercises Group

ACTIVE COMPARATOR

Participants will treated exercises with focused on upper extremity especially wrist muscles.

Other: Therapeutic Exercises

Myofascial Chains Exercises Group

EXPERIMENTAL

Participants will treated exercises with focused on whole body especilly myofascial chains.

Other: Therapeutic Exercises

Control Group

NO INTERVENTION

Participants will do any exercises. They will join only assessment sessions.

Interventions

Participants who have inclusion criterias after DRF reconstrontion pos-op 4. week will included this study. Certified Physiotherapist who have master of science degree and doctorate student will assessed them before and after treatment with face to face. Also exercise education will give face to face with same therapist. After that first sessions patients will progress their standardize or structered exercises pragram with telerehabilition during 4 weeks and 16 sessions. All sessions will be supervised with physiotherapist. End of study assessments will perform again with same therapist.

Myofascial Chains Exercises GroupUpper Extremity Exercises Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-70
  • Being able to establish written and verbal communication in Turkish
  • Post-Op rehabilitation after primary DRF surgery, at 4 weeks, post op at 6 weeks at the l latest
  • Fixation using volar plating and nailing method
  • Post-op, if instruments were left temporarily, these instruments should be removed before the study
  • No previous history of surgery involving the upper extremity
  • To have sufficient technological device usage skills and fast internet infrastructure to use video communication technologies without any problems
  • Having a device that provides the necessary equipment for video calling
  • Having a table and 6 m2 of space to allow exercise in the living area

You may not qualify if:

  • Occurrence of one of the complex regional pain syndrome subtypes after fracture
  • History of any chronic systemic, rheumatological, neurological, vascular disease
  • History of traumatic injury to intact extremities and trunk in the last 6 months
  • Presence of pain complaints including spine and shoulder pain over 3 according to the Visual Analogue Scale
  • Those who use anti-inflammatory drugs
  • Presence of cognitive or psychological illness that will prevent cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist FracturesMotor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Knowledge that which exercises are structured for research will keep from participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective Randomized Control Single-Blind Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Student

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 22, 2024

Study Start

June 2, 2021

Primary Completion

December 15, 2023

Study Completion

January 10, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations