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

NCT01289704 | Unknown Phase 2

• 1 other identifier: GUP09013
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Charcot-Marie-Tooth Disease; Charcot-Marie-Tooth Disease Type 1A

Keywords

Charcot-Marie-Tooth disease,; CMT1A,; rehabilitation,; treadmill,; stretching,; proprioception,; Randomised Controlled Trial.

Outcome Measures

Primary Outcomes (3)

• Walking ability of patients will be evaluated as the time needed to walk for 10 meters at normal speed for the patients

  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

  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

  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 Outcomes (6)

• Balance will be evaluated through the Berg Scale

  Baseline: 1 day before the rehabilitative protocol starts

• Balance will be evaluated through the Berg Scale

  at the end of treatment: day 90 (T2)

• balance will be evaluted through the Berg scale

  at the end of follow up: day 180 (T3)

• Quality of life will be evaluated through the SF - 36 questionnaire

  Baseline: 1 day before the rehabilitative protocol starts (T1)

• Quality of life will be evaluated through the SF - 36 questionnaire

  at the end of treatment: day 90 (T2)

Study Arms (2)

TreSPE

EXPERIMENTAL

Treatment with treadmill, proprioceptive and stretching exercises

Other: TreSPE

SPE

ACTIVE COMPARATOR

Proprioceptive and stretching exercises

Other: TreSPE; Other: SPE

Interventions

TreSPE OTHER

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.

Also known as: SPE

SPE; TreSPE

SPE OTHER

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.

SPE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (4)

University of Genoa

Genoa, 16132, Italy

Location

I.R.C.C.S. Foundation, Besta Institute

Milan, 20133, Italy

Location

Don Carlo Gnocchi Foundation

Rome, 00194, Italy

Location

Departement of Neurological and Visual Sciences, University of Verona

Verona, 37134, Italy

Location

Related Publications (22)

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Related Links

• Acmt-Rete is a non-profit organization made by a group of patients to help the CMT community and to promote research in the field of hereditary neuropathies

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Angelo E Schenone, MD

  University of Genova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margherita A Monti Bragadin, MD

CONTACT

0039-010-3537040; margherita.montibragadin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: February 4, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 4, 2011

Record last verified: 2010-10

Locations

IT (4)