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Not yet recruiting NCT06089863

Rehabilitation Program on Genetic and Degenerative Ataxia

No phase Interventional Ataxia Degenerative Disease Genetic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PAMPERO program.
Who it may be relevant to
Registry conditions: Ataxia, Degenerative Disease, Genetic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Effect of PAMPERO Rehabilitation Program in Collaboration With Patient Partner on the Symptom Intensity, Activity, and Quality of Life on Genetic and Degenerative Ataxia

Overview

Cerebellar ataxia is a pathology linked to the lesion of the cerebellum or the afferent and/or efferent cerebellar pathways. The aetiology can be an acquired cerebral lesion, following a chemical poisoning or a genetic degenerative lesion (for example : Friedreich's ataxia, spinocerebellar ataxias, etc.). As reported by the latest estimate available, genetic degenerative cerebellar ataxias affect approximately 6,000 patients in France (Orpha.net). Symptoms suffered by ataxic patients are : problems and gait disorders along with difficulties in coordination resulting in ataxia, uncoordinated movements. These symptoms cause a decrease in the quality of life on patients with spinocerebellar ataxia. The symptoms improvement linked to the cerebellar syndrome is based on rehabilitation that can be supplemented by use of technical aids. Current scientific knowledge confirms that intensive rehabilitation by physiotherapy and occupational therapy in patients with degenerative ataxias improves cerebellar symptoms. Nevertheless, the choice rehabilitation technique stay at the appreciation of the therapist. From the observation, the investigators have designed an intensive multidisciplinary rehabilitation program, called PAMPERO, with partner patients member of two genetic degenerative ataxia patient organisations. This 5-weeks program has been used in clinic during 3 years on 28 patients. It appears to be the only one in France. The preliminary results show a positive effect on ataxia symptom. Nevertheless, the duration of the benefice over time and the effect on the quality of life stay unknown. However, the quality of life is mainly affected by the participation restriction due to the risk of falling. The most frequent complaint from partner patient is the diminution of the social interaction resulting of the incapacity to move without risk. The present protocol aimed at evaluating the Rehabilitation Program in collaboration with partner patient on the symptom intensity, activity and quality of life on genetic and degenerative ataxia. This PAMPERO program's effect will be assessed by comparing the difference of Intensity of symptom measured by to Scale for the Assessment and Rating of Ataxia (SARA) at inclusion and 3 months after the end of rehabilitation.

Interventions

  • Other PAMPERO program
    This program is an intensive multidisciplinary program rehabilitation including Physical, Occupational, Speech, Psychomotor therapy and Adapted Physical Activity. The duration of this program is 5 weeks and each week is divided as follow : * 5 hours of physical therapy : individual session with the objective to improve the dynamic balance and coordination on the aim to gain confidence of moving, gripping capacity and interaction with object * 5 hours of Adapted Physical activity : group session

Primary outcome measures

  • Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: Inclusion ; 3 months after the end of rehabilitation]
Secondary outcome measures (12)
  • Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Score of the Mini-BESTest scale [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 3 months after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Eyes open postural surface [Time frame: 5 weeks]
  • Displacement length of the center of mass as a function of time eyes open [Time frame: 5 weeks]
  • Scale of Short Falls Efficacy Scale International (Short FES-I) [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 3 months after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Number of weekly steps [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 3 months after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Time of weekly sedentary activity [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 3 months after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Light, moderate and vigorous weekly activity [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 3 months after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Short Form Health Survey (SF-36) [Time frame: Inclusion ; Immediately or 1 week after the end of rehabilitation ; 3 months after the end of rehabilitation ; 6 months after the end of rehabilitation]
  • Number of falls during the study [Time frame: 4 weeks ; up to 3 months ; up to 6 months]
  • Number of patients who completed the entire PAMPERO program [Time frame: 5 weeks]
  • Number of patients who stopped PAMPERO program [Time frame: 5 weeks]

Eligibility criteria

Inclusion criteria

  • ≥ 18 years
  • Patients with genetic and degenerative cerebellar ataxia
  • Diagnostic of cerebellar ataxia confirmed by anatomic MRI
  • Affiliated to a social insurgence regime or similar
  • Patients who have given their free, informed and express consent
  • Walking patients (who can walk unsupervised on flat ground with the help of proper technique : categories greater than 4 on the New Functional Ambulation Classification scale)

Non inclusion Criteria:

  • Patients who have already benefited from a hospitalization of more than 3 weeks for rehabilitation during the last 12 months
  • Patients participating simultaneously in another research whose objective would be the evaluation of a therapy, medicinal or not, likely to improve neurological or functional recovery
  • Pregnants, parturient or breastfeeding
  • Patients deprived of their liberty by a judicial or administrative decision
  • Psychiatric care patients
  • Patients admitted to Patients admitted to a health or social establishment for purposes other than research for purposes other than research
  • Major patients protected by the Law

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 3 centers
  • Service de Rééducation Fonctionnelle (S.S.R.) Val Rosay — Saint-Didier-au-Mont-d'Or
  • Service de Médecine Physique et Réadaptation (M.P.R) de l'Hôpital Bellevue — Saint-Etienne
  • Service de Rééducation Fonctionnelle (S.S.R.) de l'Hôpital Henry Gabrielle Hospices Civils — Saint-Genis-Laval

Identifiers

NCT: NCT06089863 · 69HCL22_0912

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗