A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hereditary Spastic Paraplegia
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary Endpoint
- Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
Detailed Description
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
Investigators
Adam Tenforde
Physician
Spaulding Rehabilitation Hospital
Eligibility Criteria
Inclusion Criteria
- •Over the age of 18
- •Diagnosis of genetically-confirmed HSP
- •Score of 2, 3 or 4 on the PLSFRS walking question
- •30 days stable dosages of oral spasticity medications prior to screening and throughout study participation
- •Able to come to site for treatment sessions
- •Able to understand all study procedures
Exclusion Criteria
- •Diagnosis of any other neurological disorder that may impact gait
- •Lower motor neuron (LMN) disease or combined UMN and LMN
- •Non-ambulatory or requiring two-person assistance for any functional ambulation on most days
- •Less than 3 months of symptoms
- •Have received SWT within the past 3 months
- •Prior botulinum toxin injection within 3 months or planning to receive botulinum toxin injections during the study participation for spasticity management
- •Presence of an intra-thecal baclofen pump
- •Women who are pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment.
- •Patients with neuropathy affecting sensation to pain
- •Patients with a known underlying cardiac disease that could be affected by shockwave therapy
Outcomes
Primary Outcomes
Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of the rating scale ranges from 0-68, where 68 is a person who is completely asymptomatic.
Numerical Rating Scale for Pain
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
A rating of pain from 0 (none) to 10 (worst)
Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue)
Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 0 (maximally symptomatic in activities of daily living) to 84 (asymptomatic in activities of daily living).
Global Rate of Change (GROC) Questionnaire
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score ranges from -7 (maximally negative change) to +7 (maximally positive change)
Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction)
Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 0 (maximally symptomatic in sports activities) to 32 (asymptomatic in sports activities)
Ten-Meter Walk Test
Time Frame: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks
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.
Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing)
Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form
Time Frame: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function)