Condition category
Circulatory System
Date applied
20/09/2016
Date assigned
26/10/2016
Last edited
08/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Stroke is a serious, life-threatening medical condition that usually happens when a blood clot or haemorrhage cuts of the blood supply to an area of the brain. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs, but includes paralysis, muscle weakness and speech difficulties. A stroke can also have an impact on the sufferers emotions and can lead to anxiety, depression and personality changes. The PULSE study aims to measure whether wearing a device called the Timstim glove and using a pulse generator for approximately 45 minutes a day can improve the feeling and function of the hand and arm in patients who have difficulties in using the upper limbs after a stroke. There are scientific theories that by applying Repetitive Sensory Stimulation (RSS) to the upper limb, growth of new nerve cells in the brain can be encouraged. This is particularly important for stroke patients where brain cells have been destroyed during the stroke.
In this study, patients who have been treated using the TimStim glove in addition to the conventional treatment after a stroke will be compared to patients that have had conventional treatment only to see whether the glove improves upper limb function in stroke patients.

Who can participate?
Adults (aged at least 18) that have recently had a stroke that has affected the functioning of their upper limbs (arm and hand).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 receive conventional treatment. Participants in group 2 receive conventional treatment and the Timstim glove treatment. The glove works by producing electrical impulses; these are felt in the fingers as sensory pulsations.
It can be worn at any time, for example, whilst watching television or reading and the participant doesn’t have to do anything other than wear the glove. Participants are asked to wear the glove at least 45 minutes a day for three months. All participants are assessed at the start of the study, 2 weeks into the study and again 3 months later. Assessments take the form of interviews and physical arm tests.

What are the possible benefits and risks of participating?
Participants who are treated with the Timstim glove may benefit directly from taking part if the study shows that it improves recovery after stroke. Some patients also find it helpful to be part of a research study and be under regular follow-up. The result of the study will help researchers improve the future treatment/care of stroke patients. Apart from the possible inconvenience of the researcher taking up some of the participant time, there are no particular risks from taking part. In some individuals following a stroke, the limb is more susceptible and at risk of damage; •The hand may be swollen and participants may experience changes to the skin of the hand whilst wearing the glove- redness, ulcers, damage/soreness to skin. Some participants may notice a painful shoulder on the affected side or Spasticity or contractures of the affected hand. In rare cases, participants may experience an epileptic fit.

Where is the study run from?
Countess of Chester Hospital, Cheshire (UK)

When is the study starting and how long is it expected to run for?
November 2016 to May 2018

Who is funding the study?
BHR Pharmaceutical (UK)

Who is the main contact?
Professor Kausik Chatterjee
kausikchatterjee@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kausik Chatterjee

ORCID ID

http://orcid.org/0000-0002-3093-1469

Contact details

Countess of Chester NHS Foundation Trust
Chester
CH2 1UL
United Kingdom
01244362168
kausikchatterjee@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 6

Study information

Scientific title

PULSE - effect of rePetitive Upper Limb Sensory stimulation immediately after a strokE: a pilot randomised controlled trial

Acronym

PULSE

Study hypothesis

The addition of an intervention for post stroke patients –i.e. Repetitive Sensory Stimulation (RSS) via Tipstim glove plus standard treatment for stroke will prove more beneficial in improving sensory-motor function than standard treatment alone.

Ethics approval

North West - Liverpool Central Research Ethics Committee, 22/11/2016, ref: 16/NW/0771

Study design

Single centre pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Stroke

Intervention

Patients will be randomised to one of two groups- the intervention or non- intervention group; this randomisation will be computer generated and stratified according to the National Institute of Health Stroke Score (NIHSS); patients will be allocated according to their arm score- group score of 1/2 or 3/4.

Tipstim glove –the intervention.
The glove (various sizes) will be applied onto the affected hand, attached to the generator and switched on. The pulse sequence will be set individually at the highest threshold the patient can comfortably tolerate for the daily 45 minute session. This level will be recorded on each patient research record. The glove is fitted with tiny microprocessor electrodes which transmit pulses to various areas of the fingertips in a repetitive mode. These may be felt by the patient as tingles and known as sensory stimulation= RSS. The patient is free to move around if mobile, read or watch TV etc. during this 45 minutes. After 45 minutes, the researcher/patient/nurse will switch off device and remove glove and observe any adverse events- redness, swelling etc., and note any comments made by patient. The sessions will continue daily, preferably around the same time for two weeks.

Both groups will continue with standard treatment therapies as per protocol for standard care.
Standard care encompasses a variety of interventions. Treatment sessions are carried out by an occupational therapist or physiotherapist or joint occupational therapist/ physiotherapist in the treatment room, in upper limb group, in exercise group, in breakfast club, in washing and dressing activities and on home visits. Rehabilitation of the upper limb includes:

1. Task specific training/ repeated practice including:
1.1. Repetitive upper limb facilitation in function in meaningful activities of Daily Living (ADL)
1.2. De-weighting before “placing” hemi arm in space
1.3. Positioning in alignment with anticipatory postural adjustment (APA) trunk control
1.4. Scapula stabilisation and tone management
1.5. Splinting of the hand and provision of shoulder supports (Omoneurexa)
1.6.. Postural sets to allow upper limb reach and grasp activities
1.7. Napier Grip practice
1.8. Chedoke outcome measure
1.9. Facilitated “GRASP” repetitive exercises
1.10. Bedside activities including thera-putty and GRASP
1.11. Affolter approach using upper limb for co-ordination
1.12. Sensory stimulation includes:
1.13. Retrograde massage
1.14. Sensory bombardment, stimulate distal key points, open hand for reach and grasp with visual contact of palm and thumb
1.15.Contractual Hand Orientation response
1.16.Passive stretches and facilitation of full range of movement
1.17. Weight bearing and balance co-ordination

For the intervention group, face to face interviews and assessments will take place immediately on recruitment, 2 weeks later on completion of RSS intervention and 3 months later.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Change (improvement) in upper limb function at three months using the Action Research Arm Test score
2. Change (improvement) in upper limb function at three months using the Fugl-Meyer assessment of upper extremity (FMA-UE) test
3. Change (improvement) in upper limb function at three months using the Nine Hole Peg test) test
4. Safety incidence for intervention (RSS) group only:
4.1. Any damage to the skin of the hand including necrosis, ulcers occurring within 30 days of enrolment
4.2. Reasons for prematurely stopping the RSS
4.3. Epileptic seizures
4.4. Painful shoulder in the affected side
4.5. Spasticity or contractures of the affected hand
5. Users’ feedback (intervention group only): User’s feedback will be collected by organising user’s feedback meeting after approximately 10 patients have been through the two weeks of treatment. Altogether four meetings will be organised to gather their feedback. Their feedback will be collected by a semi-structured questionnaire covering the following themes:
5.1. How did they feel about using the RSS?
5.2. How easy was it to use?
5.3. Positive aspects of RSS
5.4. Negative aspects of RSS
5.5. Carers perspective on using RSS- perceived levels of spouse/patient improvement
5.6. Measures of outcomes- plus user perceived levels of improvement- psychological, physical, sensory
5.7. Overall impressions of RSS-would they carry on using it if offered and would they recommend it?

All outcomes are measured at baseline and then again at 2 weeks and 3 months.

Secondary outcome measures

1. Change (improvement) in daily living activities, assessed using the Nottingham Extended Activities of Daily Living (NEADL) score (intervention group only)
2. Change (improvement) of quality of life, assessed using the EUROQoL 5D questionnaire (intervention group only)
3. Change (improvement) in mood, assessed using the BASDEC - Brief Assessment Schedule Depression Cards score (intervention group only)

All outcomes are measured at baseline and then again at 2 weeks and 3 months.

Overall trial start date

14/11/2016

Overall trial end date

11/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 or over
2. Male and female
3. Unilateral stroke (both ischaemic and haemorrhagic) with sensory motor arm/hand weakness (2 days to 2 weeks) post stroke
4. Baseline National Institute of Health Stroke Scale (NIHSS) arm motor score of 1-4
5. Pre-stroke modified Rankin Scale (mRS) of 0-3
6. Signed informed consent or witnessed verbal consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

After analysing our local National sentinel audit for stroke data from 1st of April 2015 to 31st of March 2016, we found that 57 patients were meeting the study criteria. Therefore, it would be practical include 40 to 60 patients for this pilot trial over one year two months period.

Participant exclusion criteria

1. Patients with transient ischemic attack with symptoms lasting less than 24 hours
2. No arm weakness
3. History of epilepsy
4. Patients with permanent pacemaker
5, Aphasia, or cognitive impairment that prevented completion of the baseline assessment
6. Patients with dermatitis or oedema of the affected hand

Inclusion in another research study, including another randomised controlled trial, does not automatically exclude a patient from participating in this trial. As long as inclusion in the other study would not confound the results of this trial, co-enrolment will be permissible.

Recruitment start date

01/12/2016

Recruitment end date

11/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Countess of Chester Hospital
Chester
Cheshire
CH2 1UL
United Kingdom

Sponsor information

Organisation

Countess of Chester NHS Foundation Trust

Sponsor details

Chester
Cheshire
CH2 1UL
United Kingdom
01244362168
kausikchatterjee@nhs.net

Sponsor type

Hospital/treatment centre

Website

Organisation

BHR Pharmaceutical

Sponsor details

41 Centenary Business Centre
Nuneaton
CV11 6RY
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

BHR Pharmaceutical

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD Sharing plan:
The current data sharing plans for the study are unknown and will be made available at a later date

Intention to publish date

11/05/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/09/2017: Ethics approval information has been added.