A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population

NCT00489580 | Completed

• 1 other identifier: E-519-05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives:

1. 1.To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population.
2. 2.To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.
3. 3.To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.
4. 4.To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.

Conditions

Stroke; Hemiplegia

Keywords

stroke; weakness; motor recovery

Outcome Measures

Primary Outcomes (1)

• Hand grip strength (measured using dynamometry)

  At admission and at discharge

Secondary Outcomes (7)

• Length of Stay (days)

  The duration of the subject's inpatient hospital stay.

• Stroke Impact Scale Score

  At admission and at discharge

• Action Research Arm Test Score

  At admission and at discharge

• Ashworth Assessment (Upper Extremity) Scores

  At admission and at discharge

• Fugl-Meyer Assessment (Upper Extremity) Scores

  At admission and at discharge

Interventions

SaeboFlex Dynamic Hand Orthosis DEVICE

Saebo F.T.M. Arm Training Program PROCEDURE

Eligibility Criteria

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

You may qualify if:

• years of age or older,
• Must be seen within three full working days of admission for screening
• Alert and Oriented to person and place with the ability to complete at a minimum a one step verbal command,
• Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension
• /4 range of volitional finger flexion when the affected hand is passively positioned in a minimum of 15degrees of wrist extension with the MCP's at neutral and PIP's / DIP's in extension
• Patient must be independent with seated posture in a chair with a firm seat and back support but no arm rests
• Patient can maintain independent seated balance when unaffected upper extremity is fully outstretched in any direction
• Admitted to inpatient stroke rehabilitation at Kessler Institute

You may not qualify if:

• Inpatient physician unwilling to clear patient to participate
• Medically unsuitable for therapeutic intervention,
• Using the affected hand and arm, able to volitionally grasp and release a racquet ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more.
• Flaccidity in the affected UE or hand
• Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis.
• Hx of rheumatoid arthritis, carpal tunnel syndrome or other hand neuropathy
• Moderate to severe weeping or pitting edema
• No previous stroke prior to the one prompting admission

Sponsors & Collaborators

• Kessler Foundation: lead
• Saebo, Inc.: collaborator

Study Sites (1)

Kessler Institute for Rehabilitation

East Orange, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Asthenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elie P Elovic, M.D.

  Kessler Medical Rehabilitation Research & Education Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: August 1, 2005
• Study Completion: May 1, 2006
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

US (1)