Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

NCT03019744 | Completed Results

• 1 other identifier: RISES
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.

Conditions

Stroke

Keywords

Functional Electrical Stimulation; Cerebrovascular accident; Stroke; Electromyography

Outcome Measures

Primary Outcomes (2)

• Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment

  ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002). ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.

  5 weeks (post-treatment vs pre-treatment)

• Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment

  FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975). FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome

  5 weeks (post-treatment vs pre-treatment)

Secondary Outcomes (3)

• Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment

  5 weeks (post-treatment vs pre-treatment)

• Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment

  5 weeks (post-treatment vs pre-treatment)

• Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment

  5 weeks (post-treatment vs pre-treatment)

Study Arms (2)

MeCFES

EXPERIMENTAL

25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation

Device: MeCFES-assisted task-oriented upper limb rehabilitation

Control

ACTIVE COMPARATOR

25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation

Other: Usual Care task-oriented upper limb rehabilitation

Interventions

MeCFES-assisted task-oriented upper limb rehabilitation DEVICE

MeCFES

Usual Care task-oriented upper limb rehabilitation OTHER

Control

Eligibility Criteria

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

You may qualify if:

• Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke
• at least 1 month post-stroke
• willingness to participate the project
• minimum voluntary muscle activation of shoulder flexors (\>1 Manual Muscle Test)
• passive Range of Motion (ROM) of the shoulder and elbow of more than 90°

You may not qualify if:

• epilepsy
• severe spasticity at upper limb (\>= 3 Ashworth scale)
• implanted electronic device
• respiratory insufficiency
• pregnancy
• peripheral neuropathies
• cutaneous ulcers at the stimulation zone
• other use of FES on the upper limb

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Related Publications (4)

• van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.

  PMID: 12392340 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

• Wessels R, de Witte L, Andrich R, Ferrario M, Persson J, Oberg B, Oortwijn W, VanBeekum T, Lorentsen Ã. IPPA, a user-centered approach to assess effectiveness of assistive technology provision. Technol Disabil. 2000;13:105-15

  BACKGROUND

• Kennedy CA, Beaton DE, Solway S, McConnell S, Bombardier C. Disabilities of the Arm, Shoulder and Hand (DASH). The DASH and QuickDASH Outcome Measure User's Manual, Third Edition. Toronto, Ontario: Institute for Work & Health, 2011.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Maurizio Ferrarin
• Organization: Fondazione Don Carlo Gnocchi

mferrarin@dongnocchi.it

+390240308305

Study Officials

• Maurizio Ferrarin, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Eng., Ph.D.

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: April 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 26, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-09