Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT04530669
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2020-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy".'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': '4 weeks', 'description': 'The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.\n\nThe scale was developed by a neurologist called John Kurtzke in 1983 as an advance from his previous 10 step Disability Status Scale (DSS).\n\nThe EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.\n\nEDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems'}, {'measure': 'Functional Systems Score (FSS),', 'timeFrame': '4 weeks', 'description': 'On a scale of 0 to 6, the functional system score (FSS) measures how well the major central nervous systems are working and assigns a score to the patient disability. This score uses also information about the gait and use of assistive devices.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Tone Power Therapy', 'fatigue', 'functional outcomes'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations considered serious disorders in patients with multiple sclerosis that lead to impairment of the physical activities and disruption of the quality of life (QOL).\n\nHYPOTHESES:\n\nThis study hypothesized that:\n\nHigh Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis\n\nRESEARCH QUESTION:\n\nIs there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?', 'detailedDescription': 'Double blind randomized study including 40 patients with MS. The patients will be randomly allocated into 2 arms: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy". Either program will be applied 3 times per week for 4 weeks.\n\nThe evaluation methods will be done using:\n\n* Expanded Disability Status Scale (EDSS) / Functional Systems Score (FSS),\n* Fatigue severity scale and Modified Fatigue Impact Scale. before the exercise program and after finishing the exercise program, The assessor of the patients, before and after the program, will be blinded to the technique used (whether active or sham).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Both genders\n\n* Age from 18-50 years\n* All MS types will be included (relapsing remitting "RR", secondary progressive "SP, and primary progressive "PP")\n* Patients with residual motor / cerebellar / sphincteric impairment that are not responding to conventional pharmacological treatments.\n* At least 6 months after the last relapse.\n* EDSS from 2-6.5.\n* All patients should be receiving a disease modifying therapy with stabilization of the disease course for 1 year in case of SPMS and PPMS.\n* Patients that can pay regular visits to the physical center without potential interruption.\n* Patients who agree to participate and sign the informed consent. - body mass index (20:29) kg/m2\n\nExclusion Criteria:\n\n* cognitive impairment that can hinder the ability to communicate or to understand program instructions.\n* neurological deficits due to any disease other than MS\n* orthopedic abnormalities,\n* secondary musculoskeletal complication.\n* Patients who refuse participation or signing the informed consent.'}, 'identificationModule': {'nctId': 'NCT04530669', 'briefTitle': 'The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'P.T. REC/012/002866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program', 'interventionNames': ['Device: High Tone Power Therapy', 'Other: exercise program']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'the sham arm will receive the same physical exercise program with sham "high tone power therapy".', 'interventionNames': ['Other: exercise program']}], 'interventions': [{'name': 'High Tone Power Therapy', 'type': 'DEVICE', 'description': 'High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany).\n\nThe intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort.', 'armGroupLabels': ['study group']}, {'name': 'exercise program', 'type': 'OTHER', 'description': 'physical therapy conventional selected exercise program inform of functional activities of daily living', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Jīzah', 'state': 'Select State', 'country': 'Egypt', 'facility': 'Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.', 'geoPoint': {'lat': 31.15035, 'lon': 30.19636}}], 'overallOfficials': [{'name': 'Lama S Mahmoud', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Khalid T Turky, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ph.D., Assist. prof : Physical Therapy'}, {'name': 'Nevin M Shalaby, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lama Saad El-Din Mahmoud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery', 'investigatorFullName': 'Lama Saad El-Din Mahmoud', 'investigatorAffiliation': 'October 6 University'}}}}