Multiple SclerosisNCT02870023
How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?
A study testing Balance training and Strength training in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor control, and compromised gait function. Reduced walking speed, balance, and fatigue are the cardinal symptoms. In rehabilitation, strength and balance training are commonly used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Balance training and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with multiple sclerosis.
- Expanded Disability Status Scale (EDSS) 2.0-6.5 and min. 2.0 in the functional system "pyramidal function".
- Able to walk 100 m.
- Able to manage own transportation in relation to weekly training and tests.
- Six spot step test score > 8 sec. or Timed 25 foot walk > 5 sec.
Who cannot join
- Co-morbidity in terms of dementia and alcohol abuse.
- Attack within the last eight weeks.
- Systematic intensive rehabilitation/training within the last three months.
- Adjustment of medication within two months before inclusion. This applies only for medication that affects gait performance and spasticity.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor control, and compromised gait function. Reduced walking speed, balance, and fatigue are the cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There is increasing scientific support of strength training for improving walking function. The evidence for balance training remains flawed. It is known that neurological damage in MS leads to increased cognitive processing in the planning of movements, which predisposes fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that motoric/balance training with an emphasis on cognitive load can affect gait and fatigue.
Purpose: The aim of the study is to determine whether there is a differentiated effect between strength and balance training measured by motor function, strength, balance, and fatigue.
Read the detailed description
People with MS experience a wide variety of symptoms including impaired muscle strength and balance, fatigue, impaired cognition, depression and spasticity. Of these, impaired balance and severe fatigue are described as two of the most debilitating symptoms leading to limitations in activities such as upright posture and gait. Generally, pharmacological symptomatic treatment has not proven efficient in the treatment of balance problems, fatigue and walking impairments, with the exception that Fampridine has beneficial effects on gait performance in a subgroup of patients. Consequently, non-pharmacological interventions that effectively target these symptoms are warranted.
In the last decade progressive resistance training (PRT) has proven to be one of the promising interventions in patients with MS showing a consistent and positive effect on muscle strength. However, the effect of PRT on functional outcomes are heterogeneous but with promising effects on daily activities such as walking and chair rise. The evidence for a beneficial effect of PRT on balance and postural control is divergent and yet inadequately investigated. Regarding fatigue, a recent Cochrane review reported that one could expect improvements in MS fatigue after exercise interventions, despite methodological flaws in the existing literature, but only few studies evaluating PRT were located.
Another promising intervention is task specific training of motor function that is widely used by physiotherapists in neurorehabilitation. In this study protocol, motor function is limited to gait related functions with a particular focus put on balance and motor control, why the term Balance and Motor Control Training (BMCT) is applied. There is no universally accepted definition of human balance, but balance defined as "the inherent ability of a person to maintain, achieve or restore a specific state of balance and not to fall, with reference to the motor and sensory systems and to the physical properties of the person", is applied in this study.
Effects obtained from BMCT partly result from plastic changes in the nervous system. To induce such effects, repetition of a simple task only has limited efficiency in order to improve performance. Once a task has been learned to a certain level, further practice of the same task will not be accompanied by further induction of plasticity and little is therefore gained by continued practice of the task. To provide challenges that ensures continued learning, training exercises have to progress from simple movement trajectories to more complex movements, that also incorporates goal setting. Moreover, it has been shown that shaping and variation of tasks in combination with feedback on movement quality is of great importance for the learning outcome. The underlying concept for performing BMCT is, therefore, that improved motor control will optimize the movement strategy, which further leads to improved gait function.
Regarding the effects of BMCT on fatigue, there are diverging results in the literature, but the literature on BMCT for patients with MS is generally of low quality with an inadequate description of interventions, why further studies are warranted.
Interestingly, the principles of task specific training do fundamentally contrast the principles of PRT, that normally consist of monotonous movement patterns performed under heavy loading for a low number of repetitions. Consequently, studies comparing the effects of BMCT and PRT on gait function would add to the current literature as no studies doing so could be located. Such a comparison would help clarify whether potential effects are overlapping or differentiated and would therefore help guiding future rehabilitation interventions in persons with MS.
The primary objective of this study is, therefore, to investigate and compare the effects of 10 weeks of PRT to BMCT on gait function, balance and fatigue in mobility limited persons with MS.
It is hypothesized that PRT will be superior in improving maximal straight gait speed, whereas BMCT will have a greater impact on balance, fatigue, and more complex walking tasks that include elements of balance and coordination.
- Conditions
- Multiple Sclerosis
- Being tested
- Balance training, Strength training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
Strength trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | All sessions will start with a ten minute warm-up on either a treadmill or a cycle.
The balance intervention will be conducted in stations/domains where balance is challenged in the five different functions: standing, walking, sit to stand, stepping, and a station that exercises vestibular and gaze control.
Progression is achieved by adding exercises with increased balance requirements and by adding additional motoric and cognitive tasks to the exercises-dual-tasking.
Intensity of the exercises is defined from an error-rate where an adequate level is 20-40 percent.
The intervention is conducted according to a standardized framework that describes examples of exercises and progressions. Receives: Other: Balance training |
| Strength training | Experimental | All sessions will start with a ten minute warm-up on a stationary bicycle, followed by strength training of primary muscle synergies in the lower extremities. All exercises will be performed on machines with patients sitting or lying, adequately supported. The exercises are leg press, knee extension, hip flexion, hamstring curl, and hip extension. Exercises are performed with a fast concentric phase and a slow eccentric phase..
Set, repetition, and load:
* Weeks 1 and 2, 3 sets of 10 repetitions at a load of 15 repetitions maximum (RM)
* Weeks 3 and 4, 3 sets of 12 repetitions at a load of 12RM
* Weeks 5 and 6, 4 sets of 12 repetitions at a load of 12RM
* Weeks 7 and 8, 4 sets of 10 repetitions at a load of 10RM
* Weeks 9 and 10, 4 sets of 8 repetitions at a load of 8RM. Receives: Other: Strength training |
| Control group | No intervention | On a waitlist. After ten weeks of waiting, and intervention that contains 50 percent strength training and 50 percent balance training begins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed measured by "Six Spot Step Test"
Six Spot Step Test
Measured: At baseline and again after 10 weeks
Change in gait speed measured by "Timed 25 Foot Walk"
Timed 25 Foot Walk
Measured: At baseline and again after 10 weeks
Secondary outcomes (8)
Fatigue
Fatigue: Fatigue is measured according to the Danish version of the modified fatigue impact scale.
Measured: At baseline and after 10 weeks
Endurance
Six-minute walk
Measured: At baseline and after 10 weeks
Self-evaluated gait function
MS walking scale
Measured: At baseline and after 10 weeks
Temporospatial measures
Gait in fastest and self-selected speed is recorded by a Qualisys system for 3D analysis. Determinants are step and stride length, step width, time in swing and stance, gait speed, and hip and knee angles during gait.
Measured: At baseline and after 10 weeks
Balance - static
(modified) Clinical test for sensory interaction and balance (CTSIB). The test is conducted on a force plate that measures movement of center of pressure (COP). Outcome is length of COP trajectory and elliptic area.
Measured: At baseline and after 10 weeks
Balance - functional
Mini BESTest
Measured: At baseline and after 10 weeks
Balance - confidence
The Activities-specific Balance Confidence Scale
Measured: At baseline and after 10 weeks
Strength
Maximum voluntary isometric contraction in knee flexion and extension. Maximum voluntary isometric and isokinetic contraction in dorsal and plantar flexion.
Measured: At baseline and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- VIA University College, TrygFonden, Denmark, Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Sponsor
- Investigators
- Jacob Callesen, PT, MHSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870023
- Sponsor's protocol ID
- 14695664
- Status last verified
- Feb 2019
- First submitted
- 9 Aug 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Boes MK, Sosnoff JJ, Socie MJ, Sandroff BM, Pula JH, Motl RW. Postural control in multiple sclerosis: effects of disability status and dual task. J Neurol Sci. 2012 Apr 15;315(1-2):44-8. doi: 10.1016/j.jns.2011.12.006. Epub 2012 Jan 10.
PubMed 22236888Claros-Salinas D, Dittmer N, Neumann M, Sehle A, Spiteri S, Willmes K, Schoenfeld MA, Dettmers C. Induction of cognitive fatigue in MS patients through cognitive and physical load. Neuropsychol Rehabil. 2013;23(2):182-201. doi: 10.1080/09602011.2012.726925. Epub 2012 Nov 16.
PubMed 23153337Penner IK, Bechtel N, Raselli C, Stocklin M, Opwis K, Kappos L, Calabrese P. Fatigue in multiple sclerosis: relation to depression, physical impairment, personality and action control. Mult Scler. 2007 Nov;13(9):1161-7. doi: 10.1177/1352458507079267.
PubMed 17967844Andreasen AK, Stenager E, Dalgas U. The effect of exercise therapy on fatigue in multiple sclerosis. Mult Scler. 2011 Sep;17(9):1041-54. doi: 10.1177/1352458511401120. Epub 2011 Apr 5.
PubMed 21467189Corporaal SH, Gensicke H, Kuhle J, Kappos L, Allum JH, Yaldizli O. Balance control in multiple sclerosis: correlations of trunk sway during stance and gait tests with disease severity. Gait Posture. 2013 Jan;37(1):55-60. doi: 10.1016/j.gaitpost.2012.05.025. Epub 2012 Aug 5.
PubMed 22874664Kelleher KJ, Spence W, Solomonidis S, Apatsidis D. The characterisation of gait patterns of people with multiple sclerosis. Disabil Rehabil. 2010;32(15):1242-50. doi: 10.3109/09638280903464497.
PubMed 20156050Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.
PubMed 23200463Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24.
PubMed 22825702Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.
PubMed 19884575Huisinga JM, Filipi ML, Stergiou N. Supervised resistance training results in changes in postural control in patients with multiple sclerosis. Motor Control. 2012 Jan;16(1):50-63. doi: 10.1123/mcj.16.1.50.
PubMed 22402220Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.
PubMed 17875557Paltamaa J, Sjogren T, Peurala SH, Heinonen A. Effects of physiotherapy interventions on balance in multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2012 Oct;44(10):811-23. doi: 10.2340/16501977-1047.
PubMed 22990349Callesen J, Cattaneo D, Brincks J, Dalgas U. How does strength training and balance training affect gait and fatigue in patients with Multiple Sclerosis? A study protocol of a randomized controlled trial. NeuroRehabilitation. 2018;42(2):131-142. doi: 10.3233/NRE-172238.
PubMed 29562556
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?
- ClinicalTrials.gov ID
- NCT02870023
- Acronym / sponsor ID
- 14695664
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- VIA University College, TrygFonden, Denmark, Fondazione Don Carlo Gnocchi ETS
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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.
Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor control, and compromised gait function. Reduced walking speed, balance, and fatigue are the cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There is increasing scientific support of strength training for improving walking function. The evidence for balance training remains flawed. It is known that neurological damage in MS leads to increased cognitive processing in the planning of movements, which predisposes fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that motoric/balance training with an emphasis on cognitive load can affect gait and fatigue.
Purpose: The aim of the study is to determine whether there is a differentiated effect between strength and balance training measured by motor function, strength, balance, and fatigue.
Detailed description
People with MS experience a wide variety of symptoms including impaired muscle strength and balance, fatigue, impaired cognition, depression and spasticity. Of these, impaired balance and severe fatigue are described as two of the most debilitating symptoms leading to limitations in activities such as upright posture and gait. Generally, pharmacological symptomatic treatment has not proven efficient in the treatment of balance problems, fatigue and walking impairments, with the exception that Fampridine has beneficial effects on gait performance in a subgroup of patients. Consequently, non-pharmacological interventions that effectively target these symptoms are warranted.
In the last decade progressive resistance training (PRT) has proven to be one of the promising interventions in patients with MS showing a consistent and positive effect on muscle strength. However, the effect of PRT on functional outcomes are heterogeneous but with promising effects on daily activities such as walking and chair rise. The evidence for a beneficial effect of PRT on balance and postural control is divergent and yet inadequately investigated. Regarding fatigue, a recent Cochrane review reported that one could expect improvements in MS fatigue after exercise interventions, despite methodological flaws in the existing literature, but only few studies evaluating PRT were located.
Another promising intervention is task specific training of motor function that is widely used by physiotherapists in neurorehabilitation. In this study protocol, motor function is limited to gait related functions with a particular focus put on balance and motor control, why the term Balance and Motor Control Training (BMCT) is applied. There is no universally accepted definition of human balance, but balance defined as "the inherent ability of a person to maintain, achieve or restore a specific state of balance and not to fall, with reference to the motor and sensory systems and to the physical properties of the person", is applied in this study.
Effects obtained from BMCT partly result from plastic changes in the nervous system. To induce such effects, repetition of a simple task only has limited efficiency in order to improve performance. Once a task has been learned to a certain level, further practice of the same task will not be accompanied by further induction of plasticity and little is therefore gained by continued practice of the task. To provide challenges that ensures continued learning, training exercises have to progress from simple movement trajectories to more complex movements, that also incorporates goal setting. Moreover, it has been shown that shaping and variation of tasks in combination with feedback on movement quality is of great importance for the learning outcome. The underlying concept for performing BMCT is, therefore, that improved motor control will optimize the movement strategy, which further leads to improved gait function.
Regarding the effects of BMCT on fatigue, there are diverging results in the literature, but the literature on BMCT for patients with MS is generally of low quality with an inadequate description of interventions, why further studies are warranted.
Interestingly, the principles of task specific training do fundamentally contrast the principles of PRT, that normally consist of monotonous movement patterns performed under heavy loading for a low number of repetitions. Consequently, studies comparing the effects of BMCT and PRT on gait function would add to the current literature as no studies doing so could be located. Such a comparison would help clarify whether potential effects are overlapping or differentiated and would therefore help guiding future rehabilitation interventions in persons with MS.
The primary objective of this study is, therefore, to investigate and compare the effects of 10 weeks of PRT to BMCT on gait function, balance and fatigue in mobility limited persons with MS.
It is hypothesized that PRT will be superior in improving maximal straight gait speed, whereas BMCT will have a greater impact on balance, fatigue, and more complex walking tasks that include elements of balance and coordination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: Balance trainingAll sessions will start with a ten minute warm-up on either a treadmill or a cycle. The balance intervention will be conducted in stations/domains where balance is challenged in the five different functions: standing, walking, sit to stand, stepping, and a station that exercises vestibular and gaze control. Progression is achieved by adding exercises with increased balance requirements and by adding additional motoric and cognitive tasks to the exercises-dual-tasking. Intensity of the exercises is defined from an error-rate where an adequate level is 20-40 percent. The intervention is conducted according to a standardized framework that describes examples of exercises and progressions. |
| Strength training | Experimental | Other: Strength trainingAll sessions will start with a ten minute warm-up on a stationary bicycle, followed by strength training of primary muscle synergies in the lower extremities. All exercises will be performed on machines with patients sitting or lying, adequately supported. The exercises are leg press, knee extension, hip flexion, hamstring curl, and hip extension. Exercises are performed with a fast concentric phase and a slow eccentric phase.. Set, repetition, and load: * Weeks 1 and 2, 3 sets of 10 repetitions at a load of 15 repetitions maximum (RM) * Weeks 3 and 4, 3 sets of 12 repetitions at a load of 12RM * Weeks 5 and 6, 4 sets of 12 repetitions at a load of 12RM * Weeks 7 and 8, 4 sets of 10 repetitions at a load of 10RM * Weeks 9 and 10, 4 sets of 8 repetitions at a load of 8RM. |
| Control group | No intervention | –On a waitlist. After ten weeks of waiting, and intervention that contains 50 percent strength training and 50 percent balance training begins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with multiple sclerosis.
- Expanded Disability Status Scale (EDSS) 2.0-6.5 and min. 2.0 in the functional system "pyramidal function".
- Able to walk 100 m.
- Able to manage own transportation in relation to weekly training and tests.
- Six spot step test score > 8 sec. or Timed 25 foot walk > 5 sec.
Key exclusion criteria (4 listed)
- Co-morbidity in terms of dementia and alcohol abuse.
- Attack within the last eight weeks.
- Systematic intensive rehabilitation/training within the last three months.
- Adjustment of medication within two months before inclusion. This applies only for medication that affects gait performance and spasticity.
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 |
|---|---|---|
| Balance training | Other | Balance training |
| Strength training | Other | Strength training |
Primary outcome
Change in gait speed measured by "Six Spot Step Test"
Time frame: At baseline and again after 10 weeks
Six Spot Step Test
Change in gait speed measured by "Timed 25 Foot Walk"
Time frame: At baseline and again after 10 weeks
Timed 25 Foot Walk
8 secondary outcomes
Fatigue
Time frame: At baseline and after 10 weeks
Endurance
Time frame: At baseline and after 10 weeks
Self-evaluated gait function
Time frame: At baseline and after 10 weeks
Temporospatial measures
Time frame: At baseline and after 10 weeks
Balance - static
Time frame: At baseline and after 10 weeks
Balance - functional
Time frame: At baseline and after 10 weeks
Balance - confidence
Time frame: At baseline and after 10 weeks
Strength
Time frame: At baseline and after 10 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 19 Feb 2019.
- Background: PubMed 22236888Boes MK, Sosnoff JJ, Socie MJ, Sandroff BM, Pula JH, Motl RW. Postural control in multiple sclerosis: effects of disability status and dual task. J Neurol Sci. 2012 Apr 15;315(1-2):44-8. doi: 10.1016/j.jns.2011.12.006. Epub 2012 Jan 10.
- Background: PubMed 23153337Claros-Salinas D, Dittmer N, Neumann M, Sehle A, Spiteri S, Willmes K, Schoenfeld MA, Dettmers C. Induction of cognitive fatigue in MS patients through cognitive and physical load. Neuropsychol Rehabil. 2013;23(2):182-201. doi: 10.1080/09602011.2012.726925. Epub 2012 Nov 16.
- Background: PubMed 17967844Penner IK, Bechtel N, Raselli C, Stocklin M, Opwis K, Kappos L, Calabrese P. Fatigue in multiple sclerosis: relation to depression, physical impairment, personality and action control. Mult Scler. 2007 Nov;13(9):1161-7. doi: 10.1177/1352458507079267.
- Background: PubMed 21467189Andreasen AK, Stenager E, Dalgas U. The effect of exercise therapy on fatigue in multiple sclerosis. Mult Scler. 2011 Sep;17(9):1041-54. doi: 10.1177/1352458511401120. Epub 2011 Apr 5.
- Background: PubMed 22874664Corporaal SH, Gensicke H, Kuhle J, Kappos L, Allum JH, Yaldizli O. Balance control in multiple sclerosis: correlations of trunk sway during stance and gait tests with disease severity. Gait Posture. 2013 Jan;37(1):55-60. doi: 10.1016/j.gaitpost.2012.05.025. Epub 2012 Aug 5.
- Background: PubMed 20156050Kelleher KJ, Spence W, Solomonidis S, Apatsidis D. The characterisation of gait patterns of people with multiple sclerosis. Disabil Rehabil. 2010;32(15):1242-50. doi: 10.3109/09638280903464497.
- Background: PubMed 23200463Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.
- Background: PubMed 22825702Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24.
- Background: PubMed 19884575Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.
- Background: PubMed 22402220Huisinga JM, Filipi ML, Stergiou N. Supervised resistance training results in changes in postural control in patients with multiple sclerosis. Motor Control. 2012 Jan;16(1):50-63. doi: 10.1123/mcj.16.1.50.
- Background: PubMed 17875557Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.
- Background: PubMed 22990349Paltamaa J, Sjogren T, Peurala SH, Heinonen A. Effects of physiotherapy interventions on balance in multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2012 Oct;44(10):811-23. doi: 10.2340/16501977-1047.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
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.
Jacob Callesen, PT, MHSc principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training and Strength training in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 4 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 19 Feb 2019. 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 Denmark. 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?
Change in gait speed measured by "Six Spot Step Test" (time frame: At baseline and again after 10 weeks). The study lists 2 primary outcomes in all. 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 NCT02870023, which also lists 13 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 19 Feb 2019.