NCT04820114

Brief Summary

Distal radius fracture is the most common upper extremity fracture with peak incidence among older women after the fifth decade of life. Proprioception is one constituent of a complex Sensory motor control process. Proprioception requires the reception and central integration of incoming afferent signals. Although various sensory and motor deficits have been correlated with significant functional impairment after wrist trauma, limited research exists on the effects of proprioception and multi sensory training after distal radius fracture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

March 24, 2021

Last Update Submit

April 27, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Joint position Sense (JPS)

    Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception. Joint angle will be measured using a standard clear plastic goniometer.

    Baseline-6 months

  • Force sense (FS)

    Muscle strength (MS) is one of the most important factors affecting human performance. Force sense (FS) is also known as sense of effort / heaviness / tension or the force matching sense. It is the ability to reproduce (or match) a desired level of force one or more times.

    Baseline- 3 months

Secondary Outcomes (3)

  • Visual Analogue Scale (VAS)

    Baseline-3 months

  • Canadian Occupational Performance Measure

    Baseline-3 months

  • PRWE Patient review wrist evaluation

    Baseline-3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life.

Other: Wrist exercises

Experimental group

EXPERIMENTAL

The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase.

Other: Proprioceptive wrist exercisesOther: Wrist exercises

Interventions

Exercises for recognition of writs position and thumb force sense.

Experimental group

Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation

Control groupExperimental group

Eligibility Criteria

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

You may qualify if:

  • Patient diagnosis of distal radius fracture.
  • Wrist immobilization after lesion (unless 3 weeks)
  • Capacity for sing inform concept and understand the exercises

You may not qualify if:

  • Others associate fractures in hand or upper limb
  • Wrist ligaments injuries
  • Neurological disorder affecting the upper limb
  • Have received previous proprioceptive training for upper limb injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raquel Cantero-Téllez

Málaga, Málaga, 29012, Spain

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Raquel Cantero, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start

April 1, 2021

Primary Completion

June 1, 2021

Study Completion

January 1, 2022

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations