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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
This is a pilot study investigating the efficacy, safety, and tolerability of Extracorporeal Shockwave Therapy (ESWT) for the treatment of lower-extremity spasticity in the setting of Hereditary Spastic Paraplegia (HSP). 8 participants will be treated with shockwave therapy targeting sites of maximal spasticity in the lower extremities for 3 sessions at a rate of once per week. Participants will fill out baseline questionnaires assessing their overall wellbeing and function prior to treatment session 1, and will complete follow-up questionnaires at visit 2, visit 3, a phone call within 7 days of visit 3, and 8 weeks after initial visit. Total time enrolled in the study will be 8 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Pilot group of all 8 anticipated participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Therapy | Device | Participants will receive shockwave therapy once per week for three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale for Pain | A rating of pain from 0 (none) to 10 (worst) | 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks |
| Primary Lateral Sclerosis Functional Rating Scale (PLSFRS) | The score of the rating scale ranges from 0-68, where 68 is a person who is completely asymptomatic. | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form | The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue) | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale | The score of this questionnaire ranges from 0 (maximally symptomatic in activities of daily living) to 84 (asymptomatic in activities of daily living). | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Global Rate of Change (GROC) Questionnaire | The score ranges from -7 (maximally negative change) to +7 (maximally positive change) | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form | The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function) | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015419 | Spastic Paraplegia, Hereditary |
| ID | Term |
|---|---|
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form |
The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing) |
| 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form | The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction) | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale | The score of this questionnaire ranges from 0 (maximally symptomatic in sports activities) to 32 (asymptomatic in sports activities) | 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks |
| Ten-Meter Walk Test | Participants will be asked to walk ten meters 2x at their self-selected walking speed and 2x at their fast walking speed. Time taken to complete walks will be measured. | 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |