An interventional study of Shockwave Therapy in Hereditary Spastic Paraplegia, sponsored by Spaulding Rehabilitation Hospital. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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
150 studies on the registry are indexed under Paraplegia; 43 are open to participants now.
Browse Paraplegia studies →Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
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Exclusion Criteria:
Pilot group of all 8 anticipated participants
Device: Shockwave Therapy
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)
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital