Postpolio SyndromeNCT04387864
Whole Body Vibration on Muscle Strength in Patients With Postpolio Syndrome
A study testing Whole-body Vibration Device in people with Postpolio Syndrome, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Post-polio syndrome (PPS) is a neurological disease that affects polio survivors at least 15 years after the initial polio infection. PPS is characterized by new neurological deficiencies after a period of neurological stability, especially at least 1 decade after the initial infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpolio Syndrome
- What is being tested?
- Whole-body Vibration Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2015to 25 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having a knee flexion and extension
- muscle strength of >3/5 according to the manual muscle strength evaluation on the healthy lower extremity
- walking 300 meters alone with or without an assistive device
Who cannot join
- epilepsy
- the presence of a cardiac pacemaker
- a history of previous hip or knee prosthesis
- bleeding diathesis
- uncontrolled diabetes
- obesity (BMI≥30 kg/m2)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Faculty of Medicine, Istanbul University
Istanbul, Fatih, 34093
About this study
Official title: The Effect of Adding Whole-Body Vibration Exercises to Home Exercise Program on Muscle Strength in Patients With Postpolio Syndrome
Post-polio syndrome (PPS) is a neurological disease that affects polio survivors at least 15 years after the initial polio infection. PPS is characterized by new neurological deficiencies after a period of neurological stability, especially at least 1 decade after the initial infection. PPS may manifest as new, persistent, and progressive muscle weakness, atrophy, limb fatigability, myalgia, arthralgia, and dysphagia, but also as generalized fatigue, which typically has a considerable impact on the patients' quality of life. Whole body vibration (WBV) has become a popular form of exercise therapy especially among elderly individuals, in past decades. This training method is performed by standing on a vibrating platform which is supposed to activate muscle contractions. WBV has been studied in neurologic populations with stroke, Parkinson's disease, cerebral palsy, incomplete spinal cord injury, and multiple sclerosis.Our aim was to investigate the effectiveness of whole-body vibration (WBV) exercises performed with home exercise program and patient education in patients with postpolio syndrome (PPS) on muscle strength, fatigue, quality of life and laboratory parameters by comparing them with home exercise program and patient education alone.
Read the detailed description
Post-polio syndrome (PPS) is a neurological disease that affects polio survivors at least 15 years after the initial polio infection. The description of PPS is attributed to Jean-Martin Charcot in 1875 but was only widely recognized in the early 1980s [1].
PPS is characterized by new neurological deficiencies after a period of neurological stability, especially at least 1 decade after the initial infection. PPS may manifest as new, persistent, and progressive muscle weakness, atrophy, limb fatigability, myalgia, arthralgia, and dysphagia, but also as generalized fatigue, which typically has a considerable impact on the patients' quality of life. The estimates of the percentage of polio patients affected by PPS are inconsistent, varying between 20 and 85% depending on the diagnostic criteria applied [1].
Despite its prevalence, post-polio syndrome remains surprisingly under-researched. People with PPS generally have fewer options for exercise because it may exacerbate PPS symptoms such as pain, fatigue, and muscle weakness [2].
The pathophysiological framework relating to the genesis of PPS is based on the theory of super training, considering that shortly after an episode of acute poliomyelitis, the remaining motor neurons increase the number of sprouts for the reinnervation of muscle fibers after they have been denervated. About two to three decades after the acute episode, there is a tendency to overload this system, that can be accelerated depending on individual factors especially the activities and exercises carried out that promote overuse of the affected muscles. In this case of overuse and super training, an intense metabolic demand in the residual motor units occurs, which then triggers a process of secondary neuronal death, and active inflammatory process is present in the spinal cord with increased level of cytokines in the cerebrospinal fluid but without any convincing evidence of viral reactivation. Another hypothesis for the genesis of PPS is that it results from an autoimmune disorder, a theory that is reinforced by the presence of anti-neurofilament antibodies in the cerebrospinal fluid [1, 3, 4].
There is an ongoing process of denervation and reinnervation in the muscle fibers of motor units that survived in PPS patients. Excessive physical activity accelerates the loss of motor units. Therefore, it is very important to plan the exercise so as not to cause additional harmful effects on the integrity of the muscle and survived motor units, to ensure maximal improvement and to prevent overload.
In Cochrane review published in 2015, Koopman et al. reported that data on the effectiveness of muscle strengthening in PPS was controversial. In two studies, it was stated that strengthening thumb muscles and applying static magnetic field were reliable and effective, they increased muscle strength, but their effect on functional limitation was unknown. There is not any available data on the effectiveness of exercise for major muscle groups [5].
Whole body vibration (WBV) has become a popular form of exercise therapy especially among elderly individuals, in past decades. This training method is performed by standing on a vibrating platform which is supposed to activate muscle contractions. WBV has been studied in neurologic populations with stroke, Parkinson's disease, cerebral palsy, incomplete spinal cord injury, and multiple sclerosis, with del Pozo-Cruz et al. conducting a systematic review presenting varying results pertaining to impairments, activity limitations, and health-related quality of life. Limited data is available about the WBV in patients with polio syndrome [6].
- Conditions
- Postpolio Syndrome
- Being tested
- Whole-body Vibration Device
- Keywords
- postpolio syndrome, whole body vibration, exercises, muscle strength, poliomiyelitis
- Medical subject headings
- Postpoliomyelitis Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body Vibration DeviceDevice
Power Plate® (pro5TM; Power Plate North America, Inc., Northbrook, IL, USA)
| Study group | Role | What they receive |
|---|---|---|
| Whole-body Vibration Exercise Group | Experimental | The patients in the WBV exercise group underwent WBV exercise sessions 2 days a week (72 hours in between) for a total of 6 weeks. Each exercise session was performed under the supervision of a physician.
The patients received support from both hands on the WBV platform and both knees were positioned statically at 40-60 degree flexion (high squat position). All patients stood on the platform with sports socks (without shoes) to avoid the shoes absorbing vibration. Vibration was given by a Power Plate® device where a three-plane oscillation occurs (most vertical, Z axis). In all vibrations, 30 Hz frequency and 2 mm amplitude (low amplitude) were used. The vibration time was set to be 30 seconds in the first two weeks, 45 seconds in the next two weeks and 60 seconds in the last two weeks. The repetition of vibration was increased by 1 repetition every week, starting with 5, and 10 repetitions were given in the last week. A 1-minute rest period was given between each repetition. Receives: Device: Whole-body Vibration Device |
| Home Exercise Group | No intervention | The home program, which included isometric and isotonic exercises, was followed at home for 6 weeks. Three sets of quadriceps setting as 5 repetitions, 5-second contractions, and three sets of isotonic quadriceps exercise in seating position with weights as 12 repetitions were administered to be performed two days a week. While the patients included in the study group came for TVT exercise two days a week, the patients in the control group performed quadriceps setting exercises also on those days. The patients were invited to the physician follow-up on Wednesday every week for motivation and follow-up. The patients were asked to write their complaints during and after the exercise, if any. In addition, they were asked to note the number of repetitions and sets of their exercises on exercise booklets prepared for the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength Assessment
In our study, knee extensor and flexor muscle strengths were measured with a CybexTM (Humac) Norm 350 (Cybex Norm, Lumex Inc., Ronkonkoma, New York, USA) computed isokinetic dynamometer device. The tests were performed by an exercise physiologist with nearly 20 years of experience in isokinetic measurement and rehabilitation. It was ensured that the patients were not fasting and went to the toilet before the muscle test. Usually, the same time of day was preferred and maximum three patients were assessed per day. Each patient underwent a total of two measurements before and after the study. Care was exerted to ensure that the measurements were performed 48 hours after the end of the exercise.
Measured: 6 weeks
Secondary outcomes (4)
Fatigue Severity Scale (FSS)
It is a scale developed to measure the severity of fatigue. It is a valid and reliable assessment scale for evaluating PPS-related fatigue. The scale questions the severity of fatigue within the last month. The scale consists of 9 items and each item is rated on a 7-point scale. High scores indicate fatigue, while a score of ≥28 points indicate the presence of fatigue
Measured: 6 weeks
Fatigue Impact Scale (FIS)
The fatigue impact scale was developed to evaluate fatigue symptoms in chronic diseases or conditions. It consists of forty items. It assesses the effects of fatigue on 3 dimensions of daily life activities: cognitive function, physical function and psychosocial function. Concentration concerns, memory, thinking and organization of though are questioned in cognitive function. Strength, coordination, effort and motivation are questioned in physical function. The effects of fatigue on workload and social isolation are questioned in psychosocial function. The scale questions the last 1 month. Each question is rated between 0 (no problem) and 4 (maximum problem). The highest score is 160 points
Measured: 6 weeks
Nottingham Health Profile (NSP)
Health-related quality of life was assessed by the Nottingham Health Profile (NSP) scale, which the participants assessed themselves.
In this scale, patients are asked to answer the questions as yes and no. It includes a total of 38 items and consists of 6 dimensions. Pain and physical activity are questioned in 8 items, sleep in 5 items, fatigue in 3 items, social isolation in 5 items, and emotional reaction are questioned in 9 items. The weighted score of that item is given to each yes answer given by the patients and 0 points to each no answer. In each dimension, points are calculated separately. Each category takes a value between 0-100. Thus, health profile score is obtained
Measured: 6 weeks
Muscle Damage Assessment
Exercise is known to cause muscle damage to varying extents. Muscle damage is a condition that causes exhaustion, loss of function, weakness and pain in muscles after unfamiliar and heavy exercises. In our study, the levels of creatine kinase (CK), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were studied in the serum of the patients before and 48 hours after the exercise program ended to evaluate muscle damage.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Oct 2015
- Primary completion1 Mar 2016
- Study completion25 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postpolio SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşegül Ketenci, Prof, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387864
- Sponsor's protocol ID
- 2015/1262
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Hi Shing S, Chipika RH, Finegan E, Murray D, Hardiman O, Bede P. Post-polio Syndrome: More Than Just a Lower Motor Neuron Disease. Front Neurol. 2019 Jul 16;10:773. doi: 10.3389/fneur.2019.00773. eCollection 2019.
PubMed 31379723Bruno, R.L., The polio paradox: What you need to know. 2009: Grand Central Publishing.
Ghelman R, Akiyama IY, de Souza VT, Falcao J, Orgolini V, Hosomi JK, Quadros AAJ, Oliveira ASB. A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome. Brain Behav. 2020 Apr;10(4):e01590. doi: 10.1002/brb3.1590. Epub 2020 Mar 11.
PubMed 32162497Lo JK, Robinson LR. Postpolio syndrome and the late effects of poliomyelitis. Part 1. pathogenesis, biomechanical considerations, diagnosis, and investigations. Muscle Nerve. 2018 Dec;58(6):751-759. doi: 10.1002/mus.26168. Epub 2018 Aug 22.
PubMed 29752819Koopman FS, Beelen A, Gilhus NE, de Visser M, Nollet F. Treatment for postpolio syndrome. Cochrane Database Syst Rev. 2015 May 18;2015(5):CD007818. doi: 10.1002/14651858.CD007818.pub3.
PubMed 25984923del Pozo-Cruz B, Adsuar JC, Parraca JA, del Pozo-Cruz J, Olivares PR, Gusi N. Using whole-body vibration training in patients affected with common neurological diseases: a systematic literature review. J Altern Complement Med. 2012 Jan;18(1):29-41. doi: 10.1089/acm.2010.0691. Epub 2012 Jan 10.
PubMed 22233167Koopman FS, Brehm MA, Heerkens YF, Nollet F, Beelen A. Measuring fatigue in polio survivors: content comparison and reliability of the Fatigue Severity Scale and the Checklist Individual Strength. J Rehabil Med. 2014 Sep;46(8):761-7. doi: 10.2340/16501977-1838.
PubMed 24941350Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
PubMed 8148458Oncu J, Atamaz F, Durmaz B, On A. Psychometric properties of fatigue severity and fatigue impact scales in postpolio patients. Int J Rehabil Res. 2013 Dec;36(4):339-45. doi: 10.1097/MRR.0b013e3283646b56.
PubMed 23903028Nollet F, Beelen A, Prins MH, de Visser M, Sargeant AJ, Lankhorst GJ, de Jong BA. Disability and functional assessment in former polio patients with and without postpolio syndrome. Arch Phys Med Rehabil. 1999 Feb;80(2):136-43. doi: 10.1016/s0003-9993(99)90110-7.
PubMed 10025486
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Whole-Body Vibration Exercises to Home Exercise Program on Muscle Strength in Patients With Postpolio Syndrome
- ClinicalTrials.gov ID
- NCT04387864
- Acronym / sponsor ID
- 2015/1262
- Conditions
- Postpolio Syndrome
- Keywords
- postpolio syndrome, whole body vibration, exercises, muscle strength, poliomiyelitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-polio syndrome (PPS) is a neurological disease that affects polio survivors at least 15 years after the initial polio infection. PPS is characterized by new neurological deficiencies after a period of neurological stability, especially at least 1 decade after the initial infection. PPS may manifest as new, persistent, and progressive muscle weakness, atrophy, limb fatigability, myalgia, arthralgia, and dysphagia, but also as generalized fatigue, which typically has a considerable impact on the patients' quality of life. Whole body vibration (WBV) has become a popular form of exercise therapy especially among elderly individuals, in past decades. This training method is performed by standing on a vibrating platform which is supposed to activate muscle contractions. WBV has been studied in neurologic populations with stroke, Parkinson's disease, cerebral palsy, incomplete spinal cord injury, and multiple sclerosis.Our aim was to investigate the effectiveness of whole-body vibration (WBV) exercises performed with home exercise program and patient education in patients with postpolio syndrome (PPS) on muscle strength, fatigue, quality of life and laboratory parameters by comparing them with home exercise program and patient education alone.
Detailed description
Post-polio syndrome (PPS) is a neurological disease that affects polio survivors at least 15 years after the initial polio infection. The description of PPS is attributed to Jean-Martin Charcot in 1875 but was only widely recognized in the early 1980s [1].
PPS is characterized by new neurological deficiencies after a period of neurological stability, especially at least 1 decade after the initial infection. PPS may manifest as new, persistent, and progressive muscle weakness, atrophy, limb fatigability, myalgia, arthralgia, and dysphagia, but also as generalized fatigue, which typically has a considerable impact on the patients' quality of life. The estimates of the percentage of polio patients affected by PPS are inconsistent, varying between 20 and 85% depending on the diagnostic criteria applied [1].
Despite its prevalence, post-polio syndrome remains surprisingly under-researched. People with PPS generally have fewer options for exercise because it may exacerbate PPS symptoms such as pain, fatigue, and muscle weakness [2].
The pathophysiological framework relating to the genesis of PPS is based on the theory of super training, considering that shortly after an episode of acute poliomyelitis, the remaining motor neurons increase the number of sprouts for the reinnervation of muscle fibers after they have been denervated. About two to three decades after the acute episode, there is a tendency to overload this system, that can be accelerated depending on individual factors especially the activities and exercises carried out that promote overuse of the affected muscles. In this case of overuse and super training, an intense metabolic demand in the residual motor units occurs, which then triggers a process of secondary neuronal death, and active inflammatory process is present in the spinal cord with increased level of cytokines in the cerebrospinal fluid but without any convincing evidence of viral reactivation. Another hypothesis for the genesis of PPS is that it results from an autoimmune disorder, a theory that is reinforced by the presence of anti-neurofilament antibodies in the cerebrospinal fluid [1, 3, 4].
There is an ongoing process of denervation and reinnervation in the muscle fibers of motor units that survived in PPS patients. Excessive physical activity accelerates the loss of motor units. Therefore, it is very important to plan the exercise so as not to cause additional harmful effects on the integrity of the muscle and survived motor units, to ensure maximal improvement and to prevent overload.
In Cochrane review published in 2015, Koopman et al. reported that data on the effectiveness of muscle strengthening in PPS was controversial. In two studies, it was stated that strengthening thumb muscles and applying static magnetic field were reliable and effective, they increased muscle strength, but their effect on functional limitation was unknown. There is not any available data on the effectiveness of exercise for major muscle groups [5].
Whole body vibration (WBV) has become a popular form of exercise therapy especially among elderly individuals, in past decades. This training method is performed by standing on a vibrating platform which is supposed to activate muscle contractions. WBV has been studied in neurologic populations with stroke, Parkinson's disease, cerebral palsy, incomplete spinal cord injury, and multiple sclerosis, with del Pozo-Cruz et al. conducting a systematic review presenting varying results pertaining to impairments, activity limitations, and health-related quality of life. Limited data is available about the WBV in patients with polio syndrome [6].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body Vibration Exercise Group | Experimental | Device: Whole-body Vibration DeviceThe patients in the WBV exercise group underwent WBV exercise sessions 2 days a week (72 hours in between) for a total of 6 weeks. Each exercise session was performed under the supervision of a physician. The patients received support from both hands on the WBV platform and both knees were positioned statically at 40-60 degree flexion (high squat position). All patients stood on the platform with sports socks (without shoes) to avoid the shoes absorbing vibration. Vibration was given by a Power Plate® device where a three-plane oscillation occurs (most vertical, Z axis). In all vibrations, 30 Hz frequency and 2 mm amplitude (low amplitude) were used. The vibration time was set to be 30 seconds in the first two weeks, 45 seconds in the next two weeks and 60 seconds in the last two weeks. The repetition of vibration was increased by 1 repetition every week, starting with 5, and 10 repetitions were given in the last week. A 1-minute rest period was given between each repetition. |
| Home Exercise Group | No intervention | –The home program, which included isometric and isotonic exercises, was followed at home for 6 weeks. Three sets of quadriceps setting as 5 repetitions, 5-second contractions, and three sets of isotonic quadriceps exercise in seating position with weights as 12 repetitions were administered to be performed two days a week. While the patients included in the study group came for TVT exercise two days a week, the patients in the control group performed quadriceps setting exercises also on those days. The patients were invited to the physician follow-up on Wednesday every week for motivation and follow-up. The patients were asked to write their complaints during and after the exercise, if any. In addition, they were asked to note the number of repetitions and sets of their exercises on exercise booklets prepared for the patient. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- having a knee flexion and extension
- muscle strength of >3/5 according to the manual muscle strength evaluation on the healthy lower extremity
- walking 300 meters alone with or without an assistive device
Key exclusion criteria (7 listed)
- epilepsy
- the presence of a cardiac pacemaker
- a history of previous hip or knee prosthesis
- bleeding diathesis
- uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body Vibration DevicePower Plate® (pro5TM; Power Plate North America, Inc., Northbrook, IL, USA) | Device | Whole-body Vibration Exercise Group |
Primary outcome
Muscle Strength Assessment
Time frame: 6 weeks
In our study, knee extensor and flexor muscle strengths were measured with a CybexTM (Humac) Norm 350 (Cybex Norm, Lumex Inc., Ronkonkoma, New York, USA) computed isokinetic dynamometer device. The tests were performed by an exercise physiologist with nearly 20 years of experience in isokinetic measurement and rehabilitation. It was ensured that the patients were not fasting and went to the toilet before the muscle test. Usually, the same time of day was preferred and maximum three patients were assessed per day. Each patient underwent a total of two measurements before and after the study. Care was exerted to ensure that the measurements were performed 48 hours after the end of the exercise.
4 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: 6 weeks
Fatigue Impact Scale (FIS)
Time frame: 6 weeks
Nottingham Health Profile (NSP)
Time frame: 6 weeks
Muscle Damage Assessment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Results publication: PubMed 31379723Li Hi Shing S, Chipika RH, Finegan E, Murray D, Hardiman O, Bede P. Post-polio Syndrome: More Than Just a Lower Motor Neuron Disease. Front Neurol. 2019 Jul 16;10:773. doi: 10.3389/fneur.2019.00773. eCollection 2019.
- Results publicationBruno, R.L., The polio paradox: What you need to know. 2009: Grand Central Publishing.
- Results publication: PubMed 32162497Ghelman R, Akiyama IY, de Souza VT, Falcao J, Orgolini V, Hosomi JK, Quadros AAJ, Oliveira ASB. A twelve-week, four-arm, randomized, double-blind, placebo-controlled, phase 2 prospective clinical trial to evaluate the efficacy and safety of an anthroposophic multimodal treatment on chronic pain in outpatients with postpolio syndrome. Brain Behav. 2020 Apr;10(4):e01590. doi: 10.1002/brb3.1590. Epub 2020 Mar 11.
- Results publication: PubMed 29752819Lo JK, Robinson LR. Postpolio syndrome and the late effects of poliomyelitis. Part 1. pathogenesis, biomechanical considerations, diagnosis, and investigations. Muscle Nerve. 2018 Dec;58(6):751-759. doi: 10.1002/mus.26168. Epub 2018 Aug 22.
- Results publication: PubMed 25984923Koopman FS, Beelen A, Gilhus NE, de Visser M, Nollet F. Treatment for postpolio syndrome. Cochrane Database Syst Rev. 2015 May 18;2015(5):CD007818. doi: 10.1002/14651858.CD007818.pub3.
- Results publication: PubMed 22233167del Pozo-Cruz B, Adsuar JC, Parraca JA, del Pozo-Cruz J, Olivares PR, Gusi N. Using whole-body vibration training in patients affected with common neurological diseases: a systematic literature review. J Altern Complement Med. 2012 Jan;18(1):29-41. doi: 10.1089/acm.2010.0691. Epub 2012 Jan 10.
- Results publication: PubMed 24941350Koopman FS, Brehm MA, Heerkens YF, Nollet F, Beelen A. Measuring fatigue in polio survivors: content comparison and reliability of the Fatigue Severity Scale and the Checklist Individual Strength. J Rehabil Med. 2014 Sep;46(8):761-7. doi: 10.2340/16501977-1838.
- Results publication: PubMed 8148458Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
- Results publication: PubMed 23903028Oncu J, Atamaz F, Durmaz B, On A. Psychometric properties of fatigue severity and fatigue impact scales in postpolio patients. Int J Rehabil Res. 2013 Dec;36(4):339-45. doi: 10.1097/MRR.0b013e3283646b56.
- Results publication: PubMed 10025486Nollet F, Beelen A, Prins MH, de Visser M, Sargeant AJ, Lankhorst GJ, de Jong BA. Disability and functional assessment in former polio patients with and without postpolio syndrome. Arch Phys Med Rehabil. 1999 Feb;80(2):136-43. doi: 10.1016/s0003-9993(99)90110-7.
- Individual participant dataSharing planned: No
Related trials for Postpolio Syndrome
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Nomad P-KAFO Study
Cerebrovascular Accident, Post-polio Syndrome
Active, not recruiting
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
Spinal Cord Injuries, Poliomyelitis
RecruitingObservational study
Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
ALS (Amyotrophic Lateral Sclerosis), Postpoliomyelitis Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşegül Ketenci, Prof principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body Vibration Device in people with Postpolio Syndrome, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength Assessment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387864, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.