Self-directed Upper Limb Training Using a SaeboFlex in Acute Stroke

NCT01453010 | Unknown Early Phase 1

• 1 other identifier: 11/H0302/8
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Arm and hand weakness as a result of stroke occurs in approximately 70% of stroke survivors and causes huge loss of function and independence. A wide range of treatment approaches have been developed to improve motor recovery. Despite treatments, such as Constraint Induced Movement Therapy, showing promise, these in large have been have focused on high-intensity and repetitive task-specific practice. Patients with little hand or finger movements however may not be able to participate actively in task specific training. The SaeboFlex is a dynamic orthosis, with a spring-loaded feature that facilitates opening of the fingers and hand. This allows the patient to grasp and release objects repeatedly, hence enabling participation in repetitive task practice and increasing potential for motor recovery. Despite the SaeboFlex being used successfully in several centers in the country and internationally, research to provide evidence of effectiveness is scarce. As a consequence funding for the SaeboFlex is limited and usually requires patients' to fund their own. The study aims to explore the potential benefits and feasibility of participating in a Self-directed SaeboFlex training program to allow repetitive task practice in patients early after stroke. Subjects will undergo a 12-week training program comprising of a maximum of 3 x 45 minute sessions a day. Activities focus on grasping and releasing balls and reaching for targets, wearing the SaeboFlex for the majority of the session. At the end of each session the SaeboFlex is removed and the hand is incorporated into functional tasks as able. Subjects will be set individualized training program by a Saebo-trained therapist. The program will be graded and progressed at a rate that is appropriate to each individual. The study will measure and follow-up 8 subjects to explore improvements in recovery and functional ability of the upper limb and affect on dependency levels. It will also explore the level of intensity patients early after stroke can tolerate and how they participate in self-directed therapy. All patients will meet the inclusion criteria and be motivated to undergo the specific SaeboFlex self-directed training program. Subjects will record the time and intensity of their training sessions and also their routine upper limb therapy. Patients will be assessed before, during and after the 3 months training. If these cases show promise the study will support the need for large trials including clinical efficacy and dose finding studies.

Conditions

Stroke

Keywords

SaeboFlex; Stroke rehabilitation; Upper Limb Rehabilitation; Acute Stroke

Outcome Measures

Primary Outcomes (2)

• Action Research Arm Test (ARAT)

  Ability to use the paretic upper limb in functional activity. The ARAT is a test of upper limb function with subsections covering grasp, grip, pinch and gross movement. As the SaeboFlex is aimed at achieving grasp and release this measure appears very appropriate. It has good validity and reliability and is widely used in clinical research.

  Change from Baseline in upper limb function to 4, 8 and 12 weeks

• Motricity Index (MI)

  The Motricity Index (MI) is a clinical measure of the ability to voluntarily contract paretic muscle. It is an ordinal score with six levels of measurement within each of three categories for the upper limb (pinch grip, elbow flexion and shoulder abduction), has been used widely in clinical research, is valid, reliable and sensitive to change after stroke.

  Change from Baseline in upper limb voluntary contraction to 4, 8 and 12 weeks

Secondary Outcomes (7)

• Motor Assessment Scale- Upper Limb Section (UL-MAS).

  Change from Baseline in upper limb function to 12 weeks

• Visual Analogue Scale

  Change from Baseline to 12 weeks

• Modified Barthel Index (MBI)

  Change from Baseline in Independence level to 4, 8 and 12 weeks

• Stroke Impact Scale (SIS)

  Change from Baseline to 12 weeks

• Berg Balance Test

  Change from Baseline in balance to 4, 8 and 12 weeks

Study Arms (1)

8 individual case reviews

EXPERIMENTAL

SaeboFlex Self-directed training

Other: Self-directed Upper Limb SaeboFlex Training

Interventions

Self-directed Upper Limb SaeboFlex Training OTHER

Participants undergo a 12 week self directed upper limb training programme with the SaeboFlex upper limb orthosis. Training consists of a maximum of 3 x 45 minute sessions a day. Participants are closely monitored at least once a week by a saebo-trained therapist.

8 individual case reviews

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will:
• Be either in-patients on Colchester Stroke Unit or,
• Out-patients following an acute stroke admission to Colchester Stroke Unit
• Be adults who have suffered a stroke between 3 and 84 days before recruitment
• Have an anterior circulation stroke - i.e. must have weakness not ataxia
• Have a substantially paretic hand and fingers and meet the criteria for the SaeboFlex orthosis as below
• Have a previously fully functional upper limb (i.e. previous weakness, severe movement disorders, severe Rheumatoid Arthritis )
• Be able to participate in self directed therapy (i.e. no severe visual or cognitive deficits precluding participation task repetitive practice and recording training times)
• Are medically fit to participate in repetitive task practice as determined by the consultant (or GP if out-patient).
• Subjects must have:
• A minimum of 15 degrees passive wrist extension (fingers must be extended)
• At least 15 degrees active shoulder motion in any plane
• At least 15 degrees elbow flexion
• At least ¼ range of active finger flexion (IP) flexion

You may not qualify if:

• Patients that are able to open and close his/her hand completely, 10 times keeping the wrist neutral while maintaining his / her maximum shoulder flexion are too good for the Saebo-flex. Other treatment options should be considered.
• Severe joint deformities that could be worsened by using an orthosis, i.e. RA
• Those patients with extremely poor skin integrity which may be cause irritation or skin damage.
• We will not exclude stroke survivors on the basis of age or gender but subjects will need to be motivated for self-directed study.

Sponsors & Collaborators

• Colchester Hospital University NHS Foundation Trust: lead

Study Sites (1)

Colchester Hospital University Foundational NHS Trust

Colchester, Essex, CO45JL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Rebecca Stuck, BSc

  Colchester Hospital University Foundation NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Stuck, BSc

CONTACT

01206 745912; rebecca.stuck@colchesterhospital.nhs.uk

Lisa Marshall, Bsc

CONTACT

01206 745912; lisa.marshall@colchesterhospital.nhs.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: October 17, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

GB (1)