Evidence map›Paper›PMID 25971244›Full record

ArticleBMC neurology2015

A multi-centre, randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with Parkinson's: study protocol.

Victoria A Goodwin, Ruth Pickering, Claire Ballinger, Helen Roberts, Emma McIntosh, Sarah Lamb, Alice Nieuwboer, Lynn Rochester, Ann Ashburn, PDSAFE Protocol Development Group

Open access · goldAbstract read
In one paragraph

Article in BMC neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Interventions for preventing falls in Parkinson's disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

Victoria A GoodwinUniversity of Exeter, Exeter, UK. v.goodwin@exeter.ac.uk.
Ruth PickeringUniversity of Southampton, Southampton, UK. r.m.pickering@soton.ac.uk.
Claire BallingerUniversity of Southampton, Southampton, UK. c.ballinger@soton.ac.uk.
Helen RobertsUniversity of Southampton, Southampton, UK. hcr@soton.ac.uk.
Emma McIntoshUniversity of Glasgow, Glasgow, UK. emma.mcintosh@glasgow.ac.uk.
Sarah LambUniversity of Oxford, Oxford, UK. Sarah.lamb@ndorms.ox.ac.uk.
Alice NieuwboerUniversity of Leuven, Leuven, Belgium. Alice.Nieuwboer@faber.kuleuven.be.
Lynn RochesterNewcastle University, Newcastle, UK. Lynn.rochester@ncl.ac.uk.
Ann AshburnUniversity of Southampton, Southampton, UK. ann@soton.ac.uk.
PDSAFE Protocol Development Group
University of Southampton · GBKU Leuven · BENewcastle University · GBUniversity of Exeter · GBUniversity of Glasgow · GBUniversity of Oxford · GB

Funding

Department of Health 10/57/21Department of Health RDA/02/06/41
6 · The paper itself

Abstract

backgroundFalls amongst people with Parkinson's (PwP) result in significant disability and reduced quality of life. There is emerging evidence that exercise-based and physiotherapeutic interventions are of benefit for improving fall risk factors, such as balance. However, the benefit, in terms of preventing falls, is mixed. The development of effective interventions has been identified as the highest research priority for this population. The aim of this trial is to establish the effectiveness and cost-effectiveness of a novel, home-based physiotherapy programme, compared with usual care, on falls amongst PwP. METHODS/

designA UK multi-centre, community-based, single blind, randomised controlled trial with twelve month follow-up, and nested economic evaluation and qualitative studies will be undertaken. Six hundred PwP who live in their own home, have had one or more falls in the previous year and an MMSE score of ≥24 will be recruited. Those living in care homes and those needing assistance from another person to walk indoors will not be eligible. The intervention is a physiotherapist delivered, individually tailored and progressive, home-based programme (PDSAFE) comprising task orientated movement strategy training, functional lower limb strengthening and balance training, of six months duration. Unsupervised daily home exercises and strategies will be practised and supported using technology. Control participants will receive usual care. Data collection will include falls, cognitive state, balance and mobility, fear of falling, freezing of gait, mood, quality of life, carer quality of life and resource use. Data will be collected at baseline, three, six and twelve months. Longitudinal semi-structured interviews will be undertaken with forty participants to explore the expectations and experiences of participants. The primary outcome is risk of repeat falling at six months post-randomisation. DISCUSSION: The aims of this trial are to establish the effectiveness and cost-effectiveness of a novel, home-delivered physiotherapy intervention (PDSAFE) compared with usual care on risk of falling for PwP who have a history of falling. PDSAFE is a novel intervention that builds upon the existing literature and targeting known risk factors, being the first study that uses a novel delivery modus (technology) in conjunction with traditional physiotherapeutic approaches.

trial registrationCurrent Controlled Trials ISRCTN48152791.

Indexed as

Accidental FallsClinical ProtocolsExercise TherapyParkinsonian DisordersHumansMulticenter Studies as TopicOutcome Assessment, Health CareQuality of LifeRandomized Controlled Trials as TopicResearch DesignSingle-Blind Method

Identifiers

PMID25971244
PMCPMC4431174
OpenAlexW1766657026

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.