Design
We conducted a single blind, parallel group RCT with a focus on feasibility as a primary outcome. People with idiopathic PD were recruited from the Parkinson’s disease Association in Venice, Italy. The trial was approved by the hospital ethics committee (C.E.O.C. Brescia Italy, ref 326/2012). The trial was registered with the EudraCT (2012-005769-11). Written informed consent was obtained from the participants who scored more than 24/30 on the Mini Mental State Examination. If appropriate, written informed consent was obtained from the spouses of participants who scored less than 25/30. Participants were randomized to receive a program of either Irish set dancing or standard physiotherapy exercises for 1.5 hours once per week for 6 months.
Participants
Participants were eligible for inclusion if they had idiopathic Parkinson’s disease as diagnosed by a medical practitioner and were rated level 0–2.5 on the modified Hoehn & Yahr scale
[
21]. We included only those with mild to moderately severe PD for safety reasons as people at stage 3 or more on the Hoehn and Yahr scale have a high risk of falls. Participants were excluded if they did not speak Italian, if they had co-morbidities that prevented dancing, mobility or safe exercise, if they had received deep brain stimulation surgery or if they were unable to travel to the dancing or physiotherapy venues.
Randomization
After initial screening procedures and baseline testing, we used a blocked stratified randomization procedure, based on the modified Hoehn & Yahr (1967) score, to allocate participants to one of the two groups. We stratified according to modified Hoehn & Yahr (1967) scale scores to ensure that groups had similar proportions of those who were mild (H&Y 0–1.5) and moderately affected (2–2.5). We used computer generated number sequences for randomization and this procedure was conducted by a third party. Opaque envelopes were used to conceal allocation. Trained assessors who were blinded to group allocation conducted all of the assessments. Physiotherapists and dancing teachers providing the intervention could not be blinded to group allocation. To reduce the risk of contamination by the usual care staff becoming aware of group assignment, we therefore ensured that employers not directly involved in the study were not told of the aims, hypotheses or predictions of the trial. The therapists and dancing teachers who provided the interventions were not involved in other aspects of patient care. To test whether staff remained blind to group allocation, we asked them to guess group allocation at the end of the trial. Seven of the 24 subjects guessed their group assignment correctly.
Intervention
Participants in the Irish set dancing group received a 90 minute set dancing class weekly for six months in a dance studio located in Venice. The dance classes were held by two set dancing teachers of the Blacksheep Irish Set Dancing School in Venice, Italy. People with PD were partnered with members of the Irish set dancing school to ensure their safety, as advised by Earhart
[
22]. Family members were also invited to assist or partner the people with PD. The Irish set dancing class included a preliminary warm up consisting of range of movement, balance and postural exercises
[
23]. The goal of the warm up was to prepare people with PD for the set dancing class focusing on steps, turning, balance and posture. The class used different set dancing steps and in particular reel and polka steps. The teachers taught sets, in group formation, in four pairs of two. They were taught sets from different counties of Ireland and in particular the Corofin plain reel set, the Antrim reel set, the Black Valley Jig square, and the Durrow Threshing polka set. The sets were chosen to improve motor symptoms in Parkinson’s disease such as balance impairment, freezing of gait and hypokinesia using Irish music as a rhythmical cue
[
14]. Each class ended with a group dance in a circle and then with relaxation exercises. The protocol incorporated 10 minutes of warm up range of movement, balance and postural exercises, 70 minutes of Irish dance lessons and a 10 minutes cool down. Each person with PD was also given a video with recordings of the steps danced by the teacher. They were requested to watch the video at home once during each week, for a period of 1 hour.
The weekly standard physiotherapy exercise sessions included individual sessions delivered by a physiotherapist or physiotherapy assistant designed to improve muscle strength, mobility, balance, and postural control. The physiotherapy program was in according to the KNGF Guidelines for physical therapy in Parkinson's disease as described below. For each session each person had warm up range of movement and stretching exercises for 10 minutes followed by 50 minutes of strength training, balance training and postural re- education, then 20 minutes of gait training and a 10 minute cool down.
Each person with PD was given a video with recordings of the physiotherapy exercises. They were requested to watch the video at home once during each week, for a period of 1 hour. Over the six month intervention period, participants had on average 21.08 individual sessions of physiotherapy and 21.83 dance classes.
Details of program content
Standard physiotherapy program according to the KNGF guidelines for physical therapy in Parkinson’s disease
•Cognitive movement strategies:to divide complex automatic activities into simple movements avoiding dual tasking and to practice the movements and rehearsed in the mind.
•Cueing strategies: to improve movement and gait impairments with cueing (auditory, visual and proprioceptive cueing)
•Improvement of transfers: to train transfers by applying cognitive movement strategies and cues to initiate and continue movement
•Normalizing body posture: to preventing or treating postural deformities with exercises for postural realignment and coordinated movements
•Training reaching and grasping: to improve reaching and grasping, and manipulation of objects using cueing strategies and cognitive movement strategies avoiding dual tasking.
•Training balance: to optimize balance during the performance of activities with exercises for balance and training strength. Falls prevention strategies
•Gait training: to walk safely and to increase (comfortable) walking speed with the use of cues and cognitive movement strategies and to train musclestrength and mobility of the trunk and upper and lower limbs.
•Improvement of physical capacity: to maintain or to improve physical capacity with training of aerobic muscle strength (with the emphasis on the muscles of the trunk and legs), joint mobility (among others, axial) and muscle length (among others, muscles of the calf and hamstrings)
Outcome measures
We assessed outcomes at two time points. Baseline measures were taken within 3 weeks prior to therapy. The second assessment occurred within 3 weeks of the final week of the six month therapy period. The final assessment was 3 weeks after discharge. These time points were chosen because we wanted to evaluate the attainment and retention of skills learned during the Irish dancing course or physiotherapy classes
[
24]).
So we could compare our findings with other trials on rehabilitation outcomes in PD, we measured motor disability using the motor component of the UPDRS
[
25]. We also tested participants using the Timed Up and Go, the Berg Balance Scale and the modified Freezing of Gait Questionnaire as secondary measures of outcome. We also quantified health related quality of life in all participants using the PDQ-39. Demographic data collected at baseline included age, sex, duration PD, PD medications, cognition assessed using the Mini Mental State Examination. Although these tools have been tested for reliability and validity in other clinical trials, we wanted to examine their clinic-metric properties in relationship to a dance program over a 6 month period.
Adverse events
We recorded all adverse events such as injuries, distress, falls, deaths, and hospital admissions as a results of injures from the programs.
Statistical analysis
This clinical trial used a sample of convenience, with the assumption that 24 participants would be ample to explore safety and feasibility. For each group we compared for each variable changes in performance from admission to discharge. We also evaluated group by time interactions using repeated measures analysis of variance. We also report the effect size estimates for the treatment effects and the variance in the treatment effects. The amount of time spent in each type of therapy was recorded by a physiotherapist or therapy assistant. In addition, at the beginning of each session, participants were required to sign a form in order to attest their attendance. Data on hospital admission rates, injuries and adverse events were verified by phone interview. There were no deaths during the trial.
Set dancing may be able to help Parkinson's patients fight symptoms. Image: Belfast Trad
