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| Name | Class |
|---|---|
| Acorda Therapeutics | INDUSTRY |
| University at Buffalo | OTHER |
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The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are:
This randomized control trial examined the effectiveness of dalfampridine when administered in conjunction with 12 weeks of physical therapy compared to physical therapy and a placebo on function, quality of life (QoL) and cognition in non-ambulatory pwMS.
Specific Aim 1: Assess the change in standing tolerance, transfers, repeated sit to stand, QoL and cognitive processing for non-ambulatory individuals with MS between subjects on Dalfampridine who receive physical therapy and those who participate in physical therapy and receive a placebo. Enhancing the propagation of action potentials along axons in addition to regularly contracting the muscles through exercise may have a greater effect on strength and functional mobility.
Specific Aim 2: Assess the functional, strength and cognitive changes within all subjects receiving PT 2x a week for 12 weeks. Evidence supporting the effectiveness of physical therapy in this population is extremely limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Group | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalfampridine Pill | Drug | Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking dalfampridine 10 mg two times day |
| Measure | Description | Time Frame |
|---|---|---|
| MSQOL -54 | Baseline | |
| MSQOL -54 | 6 weeks | |
| MSQOL -54 | 12 weeks | |
| Five time Sit to Stand | Baseline | |
| Five time Sit to Stand | 6 weeks | |
| Five time Sit to Stand | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symbol Digit Modalities Test | Baseline | |
| Symbol Digit Modalities Test | 6 weeks | |
| Symbol Digit Modalities Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2011 | Apr 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2011 | Apr 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy for 12 weeks while taking Dalfampradine 10 mg two times day and Group 2 received physical therapy while taking a placebo pill two times a day.
Both investigators that were preforming the testing and treatment were blinded as to subject group assignment.
|
| Placebo | Drug | Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy 2 x a week for 12 weeks while taking a placebo pill two times day |
|
| 12 weeks |
| Wheel chair to Mat transfers - Functional Independence Measure | Baseline |
| Wheel chair to Mat transfers - Functional Independence Measure | 6 weeks |
| Wheel chair to Mat transfers - Functional Independence Measure | 12 weeks |
| Standing Tolerance | Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded. | Baseline |
| Standing Tolerance | Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded. | 6 weeks |
| Standing Tolerance | Standardized performance of static standing has not been published. For this study the subject will be positioned with the wheelchair directly in front of a sink counter. The examiner will ask the patient to stand up facing the sink counter, keeping two hands on the counter [at the sink cutout area]. The examiner will stand next to the subject and guard as needed during this task. Upon standing upright the examiner will start the stopwatch. The time will be stopped when the subject is unable to maintain an upright posture defined as flexing of the hips and knees or bending the trunk forward to lean on the counter. Two trials will be performed (separated by a 2 minute rest) with the longest time in upright standing recorded. | 12 weeks |
| 9 Hole Peg Test | Baseline |
| 9 Hole Peg Test | 6 weeks |
| 9 Hole Peg Test | 12 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |