An interventional study of PAMPERO program in Ataxia, Degenerative Disease and Genetic Disease, sponsored by Hospices Civils de Lyon. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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.
149 studies on the registry are indexed under Ataxia; 37 are open to participants now.
This study's planned enrollment of 48 is above the median of 30 across 100 interventional studies indexed under Ataxia.
Browse Ataxia studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non inclusion Criteria:
This program is an intensive multidisciplinary program rehabilitation including Physical, Occupational, Speech, Psychomotor therapy and Adapted Physical Activity.
Other: PAMPERO program
Usual Rehabilitation of the patient after the inclusion. 0 to 2 physical therapy sessions and 0 to 2 Speech therapy sessions each week usually constitute this program. This rehabilitation highly depends on the patients usual preferences. Some patients have no rehabilitation in the daily care while some have more.
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 to promote pairing with muscle building priority * 1 hour of Speech therapy : group session to educate and promote prevention strategy about dysphagia rick * 2 hours of Occupational therapy : group session to bring adaptive solution of autonomy lost with material propose, home organisation or gesture * 2 hours of Hydrotherapy : group session activity performed in water to assist rehabilitation
Scale for the Assessment and Rating of Ataxia (SARA)
Intensity of symptom measured by to Scale for the Assessment and Rating of Ataxia (SARA). Scores are from 0 to 42. An higher score is associated with a worse outcome.
Time frame: Inclusion ; 3 months after the end of rehabilitation
Scale for the Assessment and Rating of Ataxia (SARA)
Intensity of symptom measured by to Scale for the Assessment and Rating of Ataxia (SARA). Scores are from 0 to 42. An higher score is associated with a worse outcome.
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
Measure of the balance evaluate by Mini-BESTest scale (Mini-Balance Evaluation Systems Test). Scores are from 0 to 28. An higher score is associated with a better outcome.
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
Measure of the balance evaluate by the Eyes open postural surface
Time frame: 5 weeks
Displacement length of the center of mass as a function of time eyes open
Measure of the balance evaluated by the 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)
Fear of fall evaluated by to Scale of Short Falls Efficacy Scale International (Short FES-I). Scores are from 7 to 28. An higher score is associated with a worse outcome.
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
Number of steps during one week continuously measured by actimeter ActiGraph wGT3X-BT with EUROCOC (European Certificate of Conformity)
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 in minutes/day of sedentary activity during one week continuously measured by actimeter ActiGraph wGT3X-BT with EUROCOC
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
Light, moderate and vigorous activity during one week continuously measured by actimeter ActiGraph wGT3X-BT with EUROCOC
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)
Measure of the quality of life evaluate by Short Form Health Survey (SF-36). Scores are from 0 to 100. An higher score is associated with a better outcome.
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
Risk of falling evaluated by the number of falls during and outside the rehabilitation normalized on 4 weeks
Time frame: 4 weeks ; up to 3 months ; up to 6 months
Number of patients who completed the entire PAMPERO program
Number of patients who completed the entire PAMPERO program (5 weeks)
Time frame: 5 weeks
Number of patients who stopped PAMPERO program
Number of patients who stopped PAMPERO program
Time frame: 5 weeks
Time to occurrence of PAMPERO program stops
Time to occurrence of PAMPERO program stops
Time frame: 5 weeks
Reasons of PAMPERO program stops
Reasons of PAMPERO program stops
Time frame: 5 weeks
Start is estimated for Feb 2024; primary completion for Jul 2027, 41 months later.
Of 53 non-industry interventional studies with no phase under Ataxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 41 months is above that.
Counting every sponsor, half of 55 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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