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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participants will receive shockwave therapy once per week for three weeks.
Numerical Rating Scale for Pain
A rating of pain from 0 (none) to 10 (worst)
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
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)
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Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks