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This single-center observational cohort study will be conducted at Tangdu Hospital, Fourth Military Medical University. Patients presenting parkinsonism and poor levodopa response will be enrolled, including insidious-onset vascular parkinsonism (VaP) and Parkinson-plus syndromes (PPS). Within each diagnostic subgroup, participants will receive either dalfampridine 10 mg twice daily for 4 weeks combined with conventional therapy, or conventional therapy alone. Change in Timed Up and Go (TUG) time, gait speed, balance, daily function, and quality of life metrics assessed from baseline to Week 4.
Insidious-onset vascular parkinsonism (VaP) is characterized by typical clinical manifestations including gait impairment, postural instability, poor levodopa responsiveness, and diffuse cerebral white matter lesions (WMLs). Dalfampridine is an agent indicated to manage gait dysfunction among patients diagnosed with multiple sclerosis. This study will collect standardized gait and functional scale assessments in participants with insidious-onset VaP and participants with Parkinson-plus syndromes (PPS).
Single-center observational cohort study performed at Tangdu Hospital, Fourth Military Medical University, Xi'an, China. Parkinsonism and poor levodopa response will be divided into two diagnostic subgroups (VaP, PPS). Each subgroup will receive one of two treatment regimens: dalfampridine 10 mg twice daily for 4 weeks plus conventional therapy, or conventional therapy alone.
Change in Timed Up and Go (TUG) test time,10-meter walking speed, Tinetti scale score, ADL scale score, FES-I score, FOG-Q score, and SF-36 summary scores recorded at baseline and Week 4 among participants with VaP.
Baseline white matter lesion volume will be documented as a baseline clinical characteristic of all enrolled participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VaP + Dalfampridine | Patients with insidious-onset vascular parkinsonism treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks. | ||
| VaP + Conventional Therapy | Patients with insidious-onset vascular parkinsonism treated with conventional therapy alone for 4 weeks. | ||
| PPS + Dalfampridine | Patients with Parkinson-plus syndromes treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks. | ||
| PPS + Conventional Therapy | Patients with Parkinson-plus syndromes treated with conventional therapy alone for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Timed Up and Go (TUG) Time From Baseline to Week 4 | Change in the time taken to complete the Timed Up and Go (TUG) test from baseline to Week 4. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10-Meter Walk Test Speed From Baseline to Week 4 | Change in speed during the 10-Meter Walk Test from baseline to Week 4. | Baseline to Week 4 |
| Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with insidious-onset vascular parkinsonism or Parkinson-plus syndromes, with gait impairment and poor levodopa response.
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, MD, PhD | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710038 | China |
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Change in total score on the full Tinetti Balance and Gait Scale from baseline to Week 4. The scale ranges from 0 to 28; higher scores indicate superior balance and walking function.
| Baseline to Week 4 |
| Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4 | Change in total score on the full Activities of Daily Living (ADL) Scale from baseline to Week 4. Scores range from 0 to 100; higher scores reflect better daily living performance. | Baseline to Week 4 |
| Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4 | Change in total score on the full Falls Efficacy Scale-International (FES-I) from baseline to Week 4. Scores range from 16 to 64; higher scores correspond to greater fear of falling. | Baseline to Week 4 |
| Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4 | Change in total score on the full Freezing of Gait Questionnaire (FOG-Q) from baseline to Week 4. Scores range from 0 to 24; higher scores mean more severe gait freezing symptoms. | Baseline to Week 4 |
| Change in SF-36 Physical and Mental Component Summary Scores From Baseline to Week 4 | Change in Physical Component Summary and Mental Component Summary scores on the full SF-36 Health Survey from baseline to Week 4. Each summary score ranges from 0 to 100; higher scores represent better physical or mental health status. | Baseline to Week 4 |