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Status unknownNCT04820114Updated Apr 30, 2021

Proprioception and Multi Sensory Training After DRF

An interventional study of Proprioceptive wrist exercises and Wrist exercises in Distal Radius Fracture and Wrist Fracture, sponsored by University of Malaga. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of distal radius fracture (aged 18 years and above). Both assessor and statistician will remained blinded.

Standard rehabilitation program for distal radius fracture treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group, in addition, will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).

The severity of pain with activity will be measured according to the visual analog scale (VAS). PRWE questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) and force sense (FS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 3 weeks and at 12 weeks following the end of the intervention.

Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.

All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.

02

Conditions studied

  • Distal Radius Fracture
  • Wrist Fracture
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 62 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University of Malaga is the lead sponsor of 118 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • Active comparator
    Control group

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

    Other: Wrist exercises

  • Experimental
    Experimental group

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

    Other: Proprioceptive wrist exercises · Other: Wrist exercises

Interventions

  • OtherProprioceptive wrist exercises

    Exercises for recognition of writs position and thumb force sense.

  • OtherWrist exercises

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline-6 months

  2. 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.

    Time frame: Baseline- 3 months

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level.

    Time frame: Baseline-3 months

  2. Canadian Occupational Performance Measure

    Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM). The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process.

    Time frame: Baseline-3 months

  3. PRWE Patient review wrist evaluation

    PRWE is the Patient-Rated Wrist Evaluation, It is one of the reliable upper extremity outcome instrument.The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. Developed in 1998 for clinical assessment and is used for specific wrist problems.

    Time frame: Baseline-3 months

07

Study locations

1 of 1 sites recruiting
  • Raquel Cantero-Téllez
    Malaga, Málaga 29012, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04820114
Lead sponsor
University of Malaga
Responsible party
Raquel Cantero-Téllez (Principal investigator, University of Malaga) — Principal investigator
First posted
Mar 29, 2021
Start date
Apr 1, 2021
Primary completion
Jun 1, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Apr 30, 2021

Study contacts

Raquel Cantero, PhD
Contact
cantero@uma.es
0034 951952850

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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