Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment

Study design and participants This study used a pretest-posttest quasi-experimental design.

Study participants are recruited using two parallel procedures. I) Review of a hospital-based register of patients who had been treated or referred to the tonus clinic identified eligible patients, who were then sent information about the study, along with their contact information to the researcher responsible for the study. II) Patients with ongoing BoNT treatment who had been referred to the Center for Advanced Reconstruction of Extremities (C.A.R.E.), and were eligible for the present study were informed about the study and enrolment procedure.

All presumptive study participants will undergo a screening procedure by the primary examiner, to assess whether they met the study's eligibility criteria. Written informed consent will be obtained if the patient met the inclusion criteria and consented to participate. All patients are offered either of the two treatment methods, the treatment allocation are based on individual preferences. The study will be conducted in accordance with relevant ethical guidelines (Declaration of Helsinki).

The primary outcome measure are muscle tone, measured using the Modified Ashworth Scale (MAS). The single-item MAS was measured on a six-point scale from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with an additional point allocated at 1+ (slight increase in muscle tone). As such, the MAS provides a single score to represent spasticity in a specific movement. For analysis, the MAS scores of the treated muscles were summed to obtain a "composite spasticity score" for each participant.

Secondary outcomes includes measures within, body function, activity and Participation.

The calculation of sample size was based on the a priori defined difference to be detected, with an alpha level of 5% and a power goal of 80%, as well as the primary outcome variable MAS and previous findings. Provide a number of 14 participants in each of the two groups. We expected a dropout rate of 15%, and therefore aimed to include 17 individuals in each group to achieve 80% power.

Between-group differences and within-group differences in treatment efficacy will be analysed by comparing pretest-posttest changes.

The eligibility criteria for this study were as follows: 1. 18 years or above; 2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI; and 3. Patients treated at least 6 months after the injury event; and 4. Ongoing BoNT treatment in the UL, 5. A minimum of 3 months passed since the last BoNT injection: 6. At least two muscles in the hand and wrist were considered for treatment 7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment; 8. For the surgery group, medically stable to undergo surgery; 9. No other severe UL injuries affecting the functional level.

Exclusion criteria

• Under the age of 18