Multiple SclerosisNCT01507636
Occupational Therapy in Patients With Multiple Sclerosis
A study testing Occupational Therapy and Physical therapy in people with Multiple Sclerosis and Apraxia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Apraxia
- What is being tested?
- Occupational Therapy and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Dec 2012
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with all forms of MS
- Age 18-60 years
Who cannot join
- Any disease other than multiple sclerosis that could possibly explain the patient's signs and symptoms
- A relapse which started within 60 days prior to the examination
- Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, Coronary heart disease or uncompensated congestive heart failure, medication with glycosides.
- A history of drug abuse in the 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, Bern university Hospital
Bern, 3010
About this study
Official title: Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis
Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. Apraxia and impaired manual dexterity are common problems in patients with MS leading to impaired activities of daily living. However, a specific training program to improve apraxia as well as manual dexterity in MS is lacking.
In this study, the investigators want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.
Read more
Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia and manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks.
At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in all patients.
Read the detailed description
Background
Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. It impairs real object/tool use as well as pantomime and imitation of gestures affecting both sides of the body and can be a major source of disability independent of other neurological deficits. It significantly affects activities of daily living (ADL) and is associated with poorer outcome for independent living or return to work.
Apraxia is largely based on left parieto-frontal damage due to focal injury or more widespread neurodegeneration of cortical areas and/or their connections. However, apraxia has been described in damage of the right hemisphere, although less frequent and severe.
Apraxia is increasingly recognized as a clinical problem in restorative neurology and various approaches were described how to treat the disorder.
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. It is characterized by focal demyelination as well as axonal damage. MS has been classically thought of as a typical white matter disorder. However, early pathology studies and recent magnetic resonance tomography (MRI) studies show demyelination in the cortex and deep gray matter nuclei. Grey matter damage starts early in the disease and substantially affects cognitive functioning.
Apraxia and impaired manual dexterity are common problems in MS leading to impaired activities of daily living. However, a specific training program to improve apraxia and manual dexterity in MS is lacking. In this study, we want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.
It is a rater-blind, randomized, controlled trial. Patients routinely seen in our MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia using the AST (Apraxia Screen of TULIA). In case of Apraxia patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks (4 times 5 days in a row).
At study entry and study end after 4 weeks, apraxia will be tested in all patients using the extended version of the AST, the TULIA. Furthermore, a questionnaire on "activities of daily living" and "quality of life" will be evaluated, and test regarding cognition, spasticity, ataxia, fatigue as well as the EDSS will be performed.
Objective
To evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS.
Methods
see above.
- Conditions
- Multiple Sclerosis, Apraxia
- Being tested
- Occupational Therapy, Physical therapy
- Keywords
- apraxia, occupational therapy, multiple sclerosis, manual dexterity
- Medical subject headings
- Multiple Sclerosis, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
Occupational therapy using a special arm function training.
Physical therapyOther
Physical therapy for arm force training.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Occupational therapy using a special arm function training. Receives: Other: Occupational Therapy |
| Group 2 | Active comparator | Physical therapy using the Theraband for training of force. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apraxia score as measured by TULIA
Measured: From day of randomisation to end of study, expected to be after 4 weeks
Secondary outcomes (4)
Change in manual dexterity
Measured by the coin rotation task and 9-hole-peg-test
Measured: From day of randomisation to end of study, expected to be after 4 weeks
Change in activities of daily living
Measured by questionnaire
Measured: From day of randomisation to end of study, expected to be after 4 weeks
Change in quality of life
Measured by questionnaire
Measured: From day of randomisation to end of study, expected to be after 4 weeks
Change in fatigue
Measured by questionnaire
Measured: From day of randomisation to end of study, expected to be after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Christian P Kamm, MD, Principal investigator, Department of Neurology, Inselspital Bern, 3010 Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507636
- Sponsor's protocol ID
- 042/11
- Status last verified
- May 2013
- First submitted
- 4 Jan 2012
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vanbellingen T, Kersten B, Van de Winckel A, Bellion M, Baronti F, Muri R, Bohlhalter S. A new bedside test of gestures in stroke: the apraxia screen of TULIA (AST). J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):389-92. doi: 10.1136/jnnp.2010.213371. Epub 2010 Oct 9.
PubMed 20935324Bohlhalter S, Vanbellingen T, Bertschi M, Wurtz P, Cazzoli D, Nyffeler T, Hess CW, Muri R. Interference with gesture production by theta burst stimulation over left inferior frontal cortex. Clin Neurophysiol. 2011 Jun;122(6):1197-202. doi: 10.1016/j.clinph.2010.11.008. Epub 2010 Dec 3.
PubMed 21130031Kamm CP, Mattle HP, Muri RM, Heldner MR, Blatter V, Bartlome S, Luthy J, Imboden D, Pedrazzini G, Bohlhalter S, Hilfiker R, Vanbellingen T. Home-based training to improve manual dexterity in patients with multiple sclerosis: A randomized controlled trial. Mult Scler. 2015 Oct;21(12):1546-56. doi: 10.1177/1352458514565959. Epub 2015 Jan 26.
PubMed 25623246
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apraxia-specific Occupational Therapy in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01507636
- Acronym / sponsor ID
- 042/11
- Conditions
- Multiple Sclerosis, Apraxia
- Keywords
- apraxia, occupational therapy, multiple sclerosis, manual dexterity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jan 2012 (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.
Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. Apraxia and impaired manual dexterity are common problems in patients with MS leading to impaired activities of daily living. However, a specific training program to improve apraxia as well as manual dexterity in MS is lacking.
In this study, the investigators want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.
Patients routinely seen in the investigators MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia and manual dexterity. In case of Apraxia and/or impaired manual dexterity, patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks.
At study entry and study end after 4 weeks, apraxia and manual dexterity will be tested in all patients.
Detailed description
Background
Limb apraxia is defined as the inability to correctly perform skilled and/or learned limb movements, which cannot be explained by elementary motor and sensory deficits or cognitive problems. It impairs real object/tool use as well as pantomime and imitation of gestures affecting both sides of the body and can be a major source of disability independent of other neurological deficits. It significantly affects activities of daily living (ADL) and is associated with poorer outcome for independent living or return to work.
Apraxia is largely based on left parieto-frontal damage due to focal injury or more widespread neurodegeneration of cortical areas and/or their connections. However, apraxia has been described in damage of the right hemisphere, although less frequent and severe.
Apraxia is increasingly recognized as a clinical problem in restorative neurology and various approaches were described how to treat the disorder.
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. It is characterized by focal demyelination as well as axonal damage. MS has been classically thought of as a typical white matter disorder. However, early pathology studies and recent magnetic resonance tomography (MRI) studies show demyelination in the cortex and deep gray matter nuclei. Grey matter damage starts early in the disease and substantially affects cognitive functioning.
Apraxia and impaired manual dexterity are common problems in MS leading to impaired activities of daily living. However, a specific training program to improve apraxia and manual dexterity in MS is lacking. In this study, we want to evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS that have dexterity problems.
It is a rater-blind, randomized, controlled trial. Patients routinely seen in our MS consulting hour, fulfilling all inclusion and exclusion criteria and willing to participate in the study will be evaluated for Apraxia using the AST (Apraxia Screen of TULIA). In case of Apraxia patients will be randomized 1:1 using sealed envelopes to receive occupational home therapy (experimental group) or general physical exercises (control group) for 4 weeks (4 times 5 days in a row).
At study entry and study end after 4 weeks, apraxia will be tested in all patients using the extended version of the AST, the TULIA. Furthermore, a questionnaire on "activities of daily living" and "quality of life" will be evaluated, and test regarding cognition, spasticity, ataxia, fatigue as well as the EDSS will be performed.
Objective
To evaluate the impact of a targeted occupational therapy program on apraxia and manual dexterity in patients with MS.
Methods
see above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Occupational TherapyOccupational therapy using a special arm function training. |
| Group 2 | Active comparator | Other: Physical therapyPhysical therapy using the Theraband for training of force. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with all forms of MS
- Age 18-60 years
Key exclusion criteria (4 listed)
- Any disease other than multiple sclerosis that could possibly explain the patient's signs and symptoms
- A relapse which started within 60 days prior to the examination
- Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, Coronary heart disease or uncompensated congestive heart failure, medication with glycosides.
- A history of drug abuse in the 6 months prior to screening
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 |
|---|---|---|
| Occupational TherapyOccupational therapy using a special arm function training. | Other | Group 1 |
| Physical therapyPhysical therapy for arm force training. | Other | Group 2 |
Primary outcome
Change in apraxia score as measured by TULIA
Time frame: From day of randomisation to end of study, expected to be after 4 weeks
4 secondary outcomes
Change in manual dexterity
Time frame: From day of randomisation to end of study, expected to be after 4 weeks
Change in activities of daily living
Time frame: From day of randomisation to end of study, expected to be after 4 weeks
Change in quality of life
Time frame: From day of randomisation to end of study, expected to be after 4 weeks
Change in fatigue
Time frame: From day of randomisation to end of study, expected to be after 4 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 2013.
- Background: PubMed 20935324Vanbellingen T, Kersten B, Van de Winckel A, Bellion M, Baronti F, Muri R, Bohlhalter S. A new bedside test of gestures in stroke: the apraxia screen of TULIA (AST). J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):389-92. doi: 10.1136/jnnp.2010.213371. Epub 2010 Oct 9.
- Background: PubMed 21130031Bohlhalter S, Vanbellingen T, Bertschi M, Wurtz P, Cazzoli D, Nyffeler T, Hess CW, Muri R. Interference with gesture production by theta burst stimulation over left inferior frontal cortex. Clin Neurophysiol. 2011 Jun;122(6):1197-202. doi: 10.1016/j.clinph.2010.11.008. Epub 2010 Dec 3.
- Derived from this study: PubMed 25623246Kamm CP, Mattle HP, Muri RM, Heldner MR, Blatter V, Bartlome S, Luthy J, Imboden D, Pedrazzini G, Bohlhalter S, Hilfiker R, Vanbellingen T. Home-based training to improve manual dexterity in patients with multiple sclerosis: A randomized controlled trial. Mult Scler. 2015 Oct;21(12):1546-56. doi: 10.1177/1352458514565959. Epub 2015 Jan 26.
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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.
Christian P Kamm, MD principal investigator
Department of Neurology, Inselspital Bern, 3010 Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Physical therapy in people with Multiple Sclerosis and Apraxia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 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 15 May 2013. 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 Switzerland. 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 apraxia score as measured by TULIA (time frame: From day of randomisation to end of study, expected to be after 4 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 NCT01507636, which also lists 3 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 2013.