Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT07236866
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of GRAMPA Score Measuring Motor Abilities of Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the inter-rater reliability of the Motor Autonomy Assessment for the Elderly (GRAMPA) score.', 'timeFrame': 'Peri-interventional', 'description': 'Intra-class correlation coefficient (ICC). The score will therefore be calculated by 2 different professionals on the same patient during hospitalisation.\n\nScore total GRAMPA \\[0;14\\] , Score =0 significant help, Score \\[1-7\\] = partial assistance, Score \\[8-14\\] = unaided'}], 'secondaryOutcomes': [{'measure': 'Assess the convergent validity of the GRAMPA score against two established scales: Mini Moteur Test and Activities of Daily Living.', 'timeFrame': 'Baseline', 'description': 'Correlation coefficient calculated between the GRAMPA score and each of the two scales Total TMM score \\[0;20\\] A high score means good physical; ADL Score 6=independent, 4=moderate impairment, 0= very dependent'}, {'measure': 'Assess the convergent validity of the GRAMPA score against two established scales: Mini Moteur Test and Activities of Daily Living.', 'timeFrame': 'the end of the study i.e. 3 weeks on average', 'description': 'Correlation coefficient calculated between the GRAMPA score and each of the two scales Total TMM score \\[0;20\\] A high score means good physical; ADL Score 6=independent, 4=moderate impairment, 0= very dependent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor skills', 'rehabilitation'], 'conditions': ['Geriatric Assessment']}, 'descriptionModule': {'briefSummary': 'In the field of geriatrics, the Standardized Geriatric Approach (SGA) which is the benchmark for assessing elderly patients, consists of evaluating the medical, psychological and functional capacity dimensions of the elderly subject, among others.\n\nAfter a review of the literature, investigators were unable to find any scales that could study the ability to perform basic movements in a comprehensive and graded manner.\n\nScores that do assess certain aspects of motor abilities are not comprehensive, and are often based on self-reporting by the elderly or their relatives :\n\n* The AGGIR grid assesses dependency on the basis of activities performed or not performed. In addition, all basic movements are grouped together in a single item, which does not provide detailed information on the capabilities of elderly people.\n* The ADL score assesses activities of daily living, based on what patients declare. Only one item concerns basic movements, without detailing them.\n* The Tinetti score and Time up and go do not assess all basic movements, and require the patient to be able to stand to provide relevant information, whereas many geriatrics patients are unable to stand.\n\nThus, investigators created a score to assess motor abilities more comprehensively that will include the following basic movements:\n\n* Getting up in bed\n* Turning on one side in bed\n* Sitting at the edge of the bed\n* Stand up\n* Move around a small perimeter (bedroom)\n* Sitting up\n* Return to bed\n\nThe main objective is to evaluate of this study is to determine the inter-rater reliability of the GRAMPA score in elderly patients hospitalized in a geriatric rehabilitation department.', 'detailedDescription': 'In the field of geriatrics, the Standardized Geriatric Approach (SGA) which is the benchmark for assessing elderly patients, consists of evaluating the medical, psychological and functional capacity dimensions of the elderly subject, among others. This approach is defined as a "multidimensional and interdisciplinary diagnostic process that seeks to assess the medical, psychological and functional capacity of the frail elderly person, with the aim of developing a coordinated and integrated long-term treatment and follow-up plan".\n\nMobility or functional capacity, an essential component of AGS, is generally studied in terms of balance, walking and basic movement, as in the Tinetti tests, the Timed up and go or walking speed. According to the French National Authority for Health (HAS), "the ability to perform basic movements largely determines the level of physical dependence. The important stages in assessing mobility and the quality of the strategies used are: raising in bed, turning on one side in bed, getting out of bed, moving from sitting to standing and from standing to sitting\'.\n\nAfter a review of the literature, investigators were unable to find any scales that could study the ability to perform basic movements in a comprehensive and graded manner. The Minimum Motor Test (MMT), a score created in 2005 with the aim of observing motor abilities and establishing rehabilitation objectives for patients suffering from psychomotor maladjustment syndrome, does not allow exhaustive evaluation of basic movements and is not very sensitive for distinguishing between two patients unable to hold the standing position (15 items /20 requiring standing). In particular, it does not include bed raising and sit-to-stand transfers. The test is based on clinical observations using two scoring levels: if the answer to the question asked is \'yes\', the score awarded is 1; if the answer is \'no\', the score awarded is 0. The maximum total score that can be obtained is 20. A high score means that good physical ability has been retained.\n\nThe AGGIR grid assesses dependency on the basis of activities performed or not performed. In addition, all basic movements are grouped together in a single item, which does not provide detailed information on the capabilities of elderly people.\n\nThe Activities of Daily Living (ADL) assesses independence in activities of daily living in the broadest sense, but does not specifically target functional motor skills. A score of 6 determines the maximum level of autonomy. The overall score varies from 0 (totally dependent) to 6 (best possible independence). Measuring ADLs is relevant for all elderly people, regardless of where they live.\n\nThus, investigators created a score, the GRAMPA score, to assess motor abilities more comprehensively that will include the following basic movements:\n\n* Getting up in bed\n* Turning on one side in bed\n* Sitting at the edge of the bed\n* Stand up\n* Move around a small perimeter (bedroom)\n* Sitting up\n* Return to bed\n\nIn the GRAMPA score, these basic movements are characterised according to 3 grades of autonomy:\n\n* Unassisted: The patient carries out the basic movement alone, without technical aid or verbal guidance.\n* Partial assistance: The patient needs technical assistance, i.e. equipment, and/or verbal guidance to carry out the basic movement.\n* Significant assistance: The patient needs human assistance to carry out the basic movement, i.e. as soon as the carer puts his/her hands on the patient to mobilise or support him/her, and/or the carer handles the heavy equipment needed to carry out the transfer.\n\nInvestigators believe that the GRAMPA score (GRaduation de l\'Autonomie Motrice des Personnes Agées) would be a better reflection of the motor abilities of elderly subjects, by studying their ability to move in a restricted environment (e.g. a hospital room).\n\nA more accurate estimate of basic functional motor skills would help to improve communication between healthcare professionals and optimise treatment by adapting strategies to the patient\'s level of functional autonomy (patient dependence in terms of equipment layout, rehabilitation objectives and limiting iatrogenic dependence).\n\nAs the metrological qualities of the score have not been validated, it will not be used to modify the management of patients included in the study.\n\nThere will therefore be no significant benefit or risk for participating patients.\n\nPatients\' motor skills are information that is communicated very regularly between healthcare professionals, and which is essential for helping patients regain their independence and organising care in a rehabilitation department. In particular, this information can be used to choose the technical aids best suited to patients\' autonomy, or to decide on the possibility of a return home.\n\nIn particular, this score would enable better inter-professional communication about patients\' functional abilities, leading to improved conditions for patient care by professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 75 years\n2. Patients hospitalised in the medical care and rehabilitation department of the Groupe Hospitalier Mutualiste de Grenoble.\n3. Comprehension of the French language (understanding of instructions)\n4. Signature of free and informed consent\n\nExclusion Criteria:\n\n1. Patients whose sensory and/or mental capacities do not allow them to understand the instructions for carrying out transfers.\n2. Patients with medical or surgical contraindications making it impossible to carry out transfers.\n3. Patients under legal protection or unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT07236866', 'acronym': 'GRAMPA', 'briefTitle': 'Evaluation of GRAMPA Score Measuring Motor Abilities of Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Mutualiste de Grenoble'}, 'officialTitle': 'Prospective, Single-center Interventional Study to Assess the Reliability of the GRAMPA Score, Measuring the Graduation of Motor Abilities of the Elderly Patients Hospitalised', 'orgStudyIdInfo': {'id': 'GRAMPA'}, 'secondaryIdInfos': [{'id': 'Numero RCB', 'type': 'OTHER', 'domain': '2025-A00650-49'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scales Motricity', 'description': 'The motor skills will be assessed using the GRAMPA scale and compared with the scales usually used in current practice: the minimum motor test (TMM) and the Katz scale (ADL).\n\nThe GRAMPA scale will be carried out :\n\n* At admission\n* During the hospitalisation by two different physiotherapist\n* At discharge', 'interventionNames': ['Other: GRAMPA scale']}], 'interventions': [{'name': 'GRAMPA scale', 'type': 'OTHER', 'description': 'The GRAMPA scale will be carried out for every patient.\n\nThe patient will be asked to do the following basic movement, in an order defined by the physiotherapist:\n\n* Get back into bed\n* Turn on the side in bed\n* Sit on the edge of the bed\n* Stand up\n* Move around the room\n* Sitting up\n* Getting back into bed\n\nIt takes around 5 to 10 minutes to complete the scale', 'armGroupLabels': ['Scales Motricity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Isere', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adrien AM Monard, ARC', 'role': 'CONTACT', 'email': 'adrien.monard@avec.fr', 'phone': '0033 4 76 70 70 22'}, {'name': 'Corinne CC CAMARADA, ARC', 'role': 'CONTACT', 'email': 'corinne.camarada@avec.fr', 'phone': '0033 4.76.70.89.95'}], 'facility': 'Groupe Hospitalier Mutualiste de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38000', 'city': 'Grenoble', 'state': 'Isere', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'corinne cc camarada, ARC', 'role': 'CONTACT', 'email': 'corinne.camarada@avec.fr', 'phone': '33476708995'}, {'name': 'steve so odezenne, physiotherapist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Groupe Hospitalier Mutualiste', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Steve SO Odezenne, physiotherapist', 'role': 'CONTACT', 'email': 'steve.odezenne@avec.fr', 'phone': '0033 4.76.70.70.00', 'phoneExt': '7252'}, {'name': 'Charlotte CM Mathon, doctor', 'role': 'CONTACT', 'email': 'charlotte.mathon@avec.fr', 'phone': '00 33 4.76.70.70.00', 'phoneExt': '70 60'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Mutualiste de Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}