Additional Physiotherapy Sessions Focussing on Arm Rehabilitation for People After Stroke During the Early Inpatient Period? A Feasibility Study

NCT03666702 | Completed

• 1 other identifier: GN18PY228
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Weakness in the arm is common after stroke and can affect stroke survivors' ability to perform some tasks. Studies show that extra sessions of arm exercise can help them to improve their arm function and that the first 3 months is the best time to gain these benefits. A website (www.webbasedphysio.com) has been developed and evaluated for delivering and monitoring physiotherapy exercise programmes. This website has been modified for people after stroke. The purpose of this study is to assess if doing extra physiotherapy for the arm through our web-based physio website gives any extra benefits to the usual physiotherapy received on the ward. A total of 30 stroke survivors will be recruited from the acute stroke unit of Hairmyres Hospital, NHS Lanarkshire, and will be randomised into two groups: intervention (15) and control (15). The control group will receive usual care and the intervention group will receive usual care plus an augmented and individualised 4 weeks upper limb exercise programme delivered by the web-based physio. The augmented programme will comprise upper limb and trunk exercises. The duration and intensity of the programme will be based on participants' level of functional ability. For participants with low exercise capacity, the overall time of the exercise will be less to begin with and will build up over time to 30 minutes, five sessions per week (including weekends), in addition to their usual physiotherapy care. Study assessments will be at baseline, and four weeks post-intervention or just before stroke survivors are discharged, if earlier. At the end of the study, the feedback from physiotherapy staff, stroke survivors in the intervention group and their carer on the augmented web-based physiotherapy will be evaluated qualitatively and quantitatively by three questionnaires.

Conditions

Stroke

Keywords

upper limb; physiotherapy; web-based

Outcome Measures

Primary Outcomes (4)

• Adherence to augmented web-base physiotherapy programme

  Number of completed exercise sessions

  4 weeks

• Feasibility of recruitment strategy

  Number meeting the inclusion criteria invited/agreeing to participate

  11 month recruitment period

• Participant attrition

  Number of participants dropping out of the study

  1 year study period

• Participant safety - adverse events

  Number of Adverse Events

  1 year study period

Secondary Outcomes (7)

• Upper limb function

  Baseline to week 4

• Trunk Function

  Baseline to week 4

• Spasticity (MAS)

  Baseline to week 4

• Spasticity (MTS)

  Baseline to week 4

• Participant feedback

  Week 4

Study Arms (2)

Upper limb physiotherapy programme

EXPERIMENTAL

A progressive, individualised four week upper limb physiotherapy intervention programme delivered via web-based physiotherapy lasting up to 30 minutes/session, five times per week + usual care.

Other: Upper limb physiotherapy programme; Other: Usual care

Usual care

ACTIVE COMPARATOR

An average of 4 to 5 physiotherapy sessions per week, lasting approximately 45 minutes each.

Other: Usual care

Interventions

Upper limb physiotherapy programme OTHER

Web-based physio programme

Upper limb physiotherapy programme

Usual care OTHER

Usual physiotherapy care

Upper limb physiotherapy programme; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors
• moderate to severe upper limb functional limitation due to stroke (score 0-39 in the Action Research Arm Test (ARAT))
• shoulder subluxation who scored less than grade 3 (less than 1 1∕2 fingerbreadth gap) in the measure of shoulder subluxation
• diagnosed with first stroke and admitted to the rehabilitation unit
• able to sit in a chair or a bed
• able to use computer or tablet with or without help from carers
• able to understand the English language
• able to provide informed written consent
• Carers
• able to support the patient in the augmented programme (intervention group)
• able to understand and speak the English language
• Physiotherapy staff
• able to deliver and monitor the augmented programme

You may not qualify if:

• Stroke survivors
• significant cardiorespiratory, orthopaedic, neurological or other condition that would preclude them from taking part in an exercise programme
• moderate to severe cognitive impairment (score less than 25 in the Mini Mental State Examination (MMSE)
• current participation in another project

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Glasgow Caledonian University: collaborator
• NHS Lanarkshire: collaborator

Study Sites (1)

NHS Lanarkshire

Hamilton, ML3 0TA, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eileen Cowey, BSc MSc PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 12, 2018
• Study Start: November 22, 2018
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)