Treadmill, Stretching and Proprioceptive Exercise (TreSPE) Rehabilitation Program for Charcot-Marie-Tooth Neuropathy Type 1A (CMT1A) (TreSPE)

February 3, 2011 updated by: University of Genova

A Multicenter Study to Evaluate the Effects on Charcot-Marie-Tooth Neuropathy Type 1A of a Composite Treadmill, Stretching and Proprioceptive Exercise (TreSPE) Rehabilitation Program.

Charcot-Marie-Tooth neuropathy type 1A (CMT1A) is one of the most common inherited neurological disorders. The study will evaluate the efficacy and safety of an innovative rehabilitation protocol constituted by exercises at the treadmill and by a stretching and proprioceptive approach. A total of 92 patients will be enrolled in the study and treated in a controlled, randomized, single blind, way. To recruit a high number of patients with CMT1A the study will be multicentric and will comprehend four of the most active clinical centers in the field of CMT, in Italy. People with CMT1A are very motivated in entering rehabilitation protocols because to date there is no effective therapy for this disease. Therefore, the investigators expect a high compliance by the patients. With the present project the investigators plan to clarify several unanswered questions: 1) the efficacy and safety of treadmill over a more conventional protocol; 2) the duration and frequency of any rehabilitation treatment; 3) the most sensitive outcome measures to evaluate the efficacy of rehabilitation approach in patients with CMT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A multicentre, prospective, randomised, controlled, single blind study to evaluate the impact of aerobic exercise, based on a tightly controlled program at the treadmill, on the rehabilitation therapy of CMT 1A neuropathy.

Comparing aerobic training at the treadmill combined with respiratory physiotherapy, stretching and proprioceptive exercises (TreSPE- treated group) with a more conventional treatment only composed by respiratory physiotherapy, stretching and proprioceptive exercises (SPE- control group) will provide information on the impact of Treadmill in CMT1A.

92 patients (23 per centre) will be enrolled and randomly assigned to TreSPE (n = 46) or to SPE (n = 46). Both groups will be treated for three months and followed up for six months.

No serious side effects are expected with TreSPE, as also suggested by our preliminary results. For safety reasons blood pressure (BP), heart rate (HR) and an electrocardiogram will be recorded during the rehabilitation treatment when the treating physician considers it necessary. The patients will be allowed, if needed, to hold at the parallel bars of the treadmill during exercise. According to the American Thoracic Society (ATS) guidelines the cardiopulmonary exercise test will be interrupted if BP raises at 240/120 and/or HR to 220-patients age.

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • University of Genoa
      • Milan, Italy, 20133
        • I.R.C.C.S. Foundation, Besta Institute
      • Rome, Italy, 00194
        • Don carlo Gnocchi Foundation
      • Verona, Italy, 37134
        • Departement of Neurological and Visual Sciences, University of Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of CMT1A
  • Genetic confirmation (17p112 chromosome duplication)
  • Age 18 - 70 years old
  • Ability to accomplish the primary outcome measure (10 meter walking test) without support, with or without ankle foot orthoses (AFO)
  • Ability to walk on a treadmill on a horizontal plane for 20 minutes at a speed of 1.5 km/h with or without support at the bars
  • Score at the Mobility Scale between 2 and 11
  • Signed written informed consent to participate

Exclusion Criteria:

  • Diagnosis of Hereditary Neuropathy with Liability to Pressure Palsies (HNPP) or any other type of CMT
  • Other associated causes of neuropathy
  • Vestibular affections, psychiatric, cardiovascular and lung disorders or severe arthropathic changes in the lower limbs
  • Non ambulating patients or patients always requiring even monolateral support to walk
  • Other neurological disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TreSPE
Treatment with treadmill, proprioceptive and stretching exercises
Other: TreSPE
  1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
  2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
  3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
  4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
  5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
Other Names:
  • SPE
Active Comparator: SPE
Proprioceptive and stretching exercises
Other: TreSPE
  1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
  2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
  3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
  4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
  5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
Other Names:
  • SPE
Other: SPE
  1. Respiratory Physiotherapy for 20', consisting of Positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training according to the Mèzières technique, for the other 10'.
  2. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors longus and brevis, both at the bed and in a static position.
  3. Proprioceptive and postural kinesitherapy according to the neurocognitive method.
  4. Balance Exercising consists of exercises carried on by moving bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handlebar preventing falls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking ability of patients will be evaluated as the time needed to walk for 10 meters at normal speed for the patients
Time Frame: Baseline: 1 day before the rehabilitative protocol starts (T1)
The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).
Baseline: 1 day before the rehabilitative protocol starts (T1)
Walking ability of patients will be evaluated after finishing the treatment as the time needed to walk for 10 meters at normal speed for the patients
Time Frame: at the end of treatment: day 90 (T2)
The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).
at the end of treatment: day 90 (T2)
Walking ability of patients will be evaluated after finishing the treatment as the time needed to walk for 10 meters at normal speed for the patients
Time Frame: at the end of follow up: day 180 (T3)
The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).
at the end of follow up: day 180 (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance will be evaluated through the Berg Scale
Time Frame: Baseline: 1 day before the rehabilitative protocol starts
The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal
Baseline: 1 day before the rehabilitative protocol starts
Balance will be evaluated through the Berg Scale
Time Frame: at the end of treatment: day 90 (T2)
The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal
at the end of treatment: day 90 (T2)
balance will be evaluted through the Berg scale
Time Frame: at the end of follow up: day 180 (T3)
The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal
at the end of follow up: day 180 (T3)
Quality of life will be evaluated through the SF - 36 questionnaire
Time Frame: Baseline: 1 day before the rehabilitative protocol starts (T1)
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Baseline: 1 day before the rehabilitative protocol starts (T1)
Quality of life will be evaluated through the SF - 36 questionnaire
Time Frame: at the end of treatment: day 90 (T2)
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
at the end of treatment: day 90 (T2)
Quality of life will be evaluated through the SF - 36 questionnaire
Time Frame: at the end of follow up: day 180 (T3)
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
at the end of follow up: day 180 (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Genova

Investigators

  • Principal Investigator: Angelo E Schenone, MD, University of Genova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 4, 2011

Study Record Updates

Last Update Posted (Estimate)

February 4, 2011

Last Update Submitted That Met QC Criteria

February 3, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUP09013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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