NCT06425952

Brief Summary

Charcot-Marie-Tooth (CMT), a therapeutically orphan neuromuscular disease affecting one in 2,500 people, represents a challenge to the medical and scientific communities. Physiotherapeutic-rehabilitative strategies play a crucial role in the management of CMT, particularly addressing balance impairment, a key disabling symptom. However, clinical studies in this field are limited. Our study aims to investigate the impact of strengh and somatosensory deficits on static and dynamic balance in CMT patients. The Investigators also aim to explore the involvement of the vestibular system and its correlation with postural instability. Furthermore, the Investigators seek to evaluate relationships between neurochemical biomarkers offering valuable insights for future targeted clinical studies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
May 2024May 2026

Study Start

First participant enrolled

May 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 17, 2024

Last Update Submit

May 22, 2024

Conditions

Hereditary Neuropathy

Keywords

CMT neuropathyequilibrium

Outcome Measures

Primary Outcomes (1)

  • Postural equilibrium

    How sensory and motor deficit influence the postural equilibrium

    12 months

Secondary Outcomes (1)

  • Vestibular equilibrium

    12 months

Study Arms (4)

CMT patients

patients with sensory-motor genetic neuropathy

Motor patients

Patients with motor genetic neuropathy

Sensory patients

Patients with sensory neuropathy

Myopathic patients

Patients with distal myopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10 CMT1A patient, 10 CMT2, 10 HMN, 10 sensory neuropathies, 10 distal myopathies, 10 healthy controls.

You may qualify if:

  • CMT or HMN or sensory neuropathy or distal myopathy

You may not qualify if:

  • unable to stand
  • other neurological, psychiatric, or orthopedic disorders
  • MMSE \<28
  • alcohol abuse
  • intensive rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Study Officials

  • Stefano C Previtali, MD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano C Previtali, MD

CONTACT

00390226433036neuromuscolare@hsr.it

Benedetta Sorrenti, MD

CONTACT

00390226433036neuromuscolare@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Neuromuscular Repair Unit

Study Record Dates

First Submitted

May 17, 2024

First Posted

May 23, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)