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Completed

NCT Number: NCT01936298

Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Habilita, Ospedale di Sarnico

Sarnico, Bergamo, 24067, Italy

About this study

We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.

We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a history of acute phase of stroke (less than 12 months post onset),
  • first stroke episode,
  • no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
  • no contracture of the affected wrist or fingers (Modified Ashworth<3),
  • no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
  • for P-ROM patients, the absence of active hand movements,
  • for the A-ROM patients, the presence of active hand movements.

Exclusion criteria

  • unstable medical disorders,
  • active Complex Regional Pain Syndrome (CRPS),
  • severe spatial neglect,
  • aphasia,
  • cognitive problems.

Treatment and study plan

A-ROM Continuous Passive Rehabilitation

Device

Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).

Other names: Continuous Passive Motion device for hand: Gloreha

P-ROM Continuous Passive Rehabilitation

Device

Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).

Other names: Continuous Passive Motion device for hand: Gloreha

Primary outcomes

  1. Change from Baseline of Perimeter edema

    Time frame: 1 day after the treatment

Secondary outcomes

  1. Change from Baseline of Visual analogue scale (VAS)

    Time frame: 1 day after the treatment

  2. Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)

    Time frame: 1 day after the treatment

  3. Change from Baseline of Range Of Motion (ROM)

    Time frame: 1 day after the treatment

  4. Clinical Global Impression (CGI)

    Time frame: 1 day after the treatment

Sponsors and collaborators

Lead sponsor

Chiara Mulé

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2013
Registry last updated
Oct 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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