Does cycling with electrical stimulation (ES) improve strength and walking ability in people with an acquired brain injury? A randomised controlled trial

Not Applicable

Completed

• Conditions: Acquired brain injury; Physical Medicine / Rehabilitation - Physiotherapy; Neurological - Other neurological disorders

• Registration Number: ACTRN12612001163897
• Lead Sponsor: Davide de Sousa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. diagnosis of a first time stroke or any other acquired brain injury that is not progressive resulting in hemiparesis
2. acute event < 6 months before the study onset
3. sufficient cognition to consent (as evaluated by a physician) or consent will be obtained from the next of kin.
4. sufficient communication to indicate yes/no verbally or via gestures possible discomfort.
5. able to sit supported for 40 mins

Exclusion Criteria

1. limited joint range of movement or musculoskeletal conditions that would prevent pedaling
2. cardiac pacemakers unless permission to participate by a medical officer
3. skin reaction to the electrodes
4. inability to tolerate or be stimulated by electrical stimulation
5. poor skin viability
6. pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quadriceps strength will be measured using dynamometry, a hand-held device which is easy to use and not harmful to the participant.[Measured prior to randomization and again following the intervention period of 4 weeks.];Walking ability will be assessed using the transfers and locomotion items of the Functional Independence Measure (FIM).[Measured prior to randomization and again following the intervention period of 4 weeks.]

Secondary Outcome Measures

Name	Time	Method
Spasticity will be assessed using the Tardieu scale[Measured prior to randomization and again following the intervention period of 4 weeks.];Global lower limb strength will be measured with manual muscle testing.[Measured prior to randomization and again following the intervention period of 4 weeks.]