Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19

NCT ID: NCT06137716

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-02-01

Brief Summary

Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.

Conditions

Robotic Exoskeleton; Post-acute Covid-19 Syndrome; Rehabilitation Outcome; Physical And Rehabilitation Medicine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant Group/Arm

Participants will rehabilitation with a robotic hand exoskeleton.

Group Type: EXPERIMENTAL

Training with a Robotic Hand Exoskeleton

Intervention Type: DEVICE

The rehabilitation program extended over six consecutive weeks. Each therapy session, lasting 45 minutes, occurred four times per week, resulting in a total of 24 sessions. Within each session, a total of six exercises, consisting of three passive exercises and three bilateral exercises, were performed in an alternating manner. The exercises were executed in the following sequence: 1) Bilateral hand opening and closing; 2) Passive independent finger opening and closing; 3) Bilateral pinch; 4) Passive hand opening and closing; 5) Bilateral hand opening and closing based on a VR-based game involving squeezing an orange; 6) Passive pinch.

Interventions

Training with a Robotic Hand Exoskeleton

The rehabilitation program extended over six consecutive weeks. Each therapy session, lasting 45 minutes, occurred four times per week, resulting in a total of 24 sessions. Within each session, a total of six exercises, consisting of three passive exercises and three bilateral exercises, were performed in an alternating manner. The exercises were executed in the following sequence: 1) Bilateral hand opening and closing; 2) Passive independent finger opening and closing; 3) Bilateral pinch; 4) Passive hand opening and closing; 5) Bilateral hand opening and closing based on a VR-based game involving squeezing an orange; 6) Passive pinch.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Over 30 years old
• Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
• Patients with acute or limited functional or strength impairment in at least one of the upper extremities
• Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
• Patients who give inform written consent.

Exclusion Criteria

• Presence of behavioral disorders
• Dementia (loss of memory of cognitive functions)
• Disorders of consciousness (confusional states and drowsiness)
• Uncontrolled or severely limiting delusions and hallucinations
• Infectious skin diseases
• Rrisk of epileptic seizures due to COVID itself or prior to it
• Severe visual impairments
• Severe spasticity with a Modified Ashworth Scale >2, joint stiffness in the wrist and fingers
• Pain with a score >8 on the Visual Analog Scale (VAS) during mobilization of the affected hand.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalario Padre Benito Menni

UNKNOWN

Sponsor Role: collaborator

University of Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Juan Carlos Fraile

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Hospitalario Padre Benito Menni

Valladolid, , Spain

Countries

Spain

References

Cisnal A, Alonso-Linaje G, Fraile JC, Perez-Turiel J, Alvarez P, Martinez S. Tackling Post-COVID-19 Rehabilitation Challenges: A Pilot Clinical Trial Investigating the Role of Robotic-Assisted Hand Rehabilitation. J Clin Med. 2024 Mar 7;13(6):1543. doi: 10.3390/jcm13061543.

Reference Type: DERIVED

PMID: 38541769 (View on PubMed)

Other Identifiers

CASVE-NM-22-575

Identifier Type: -

Identifier Source: org_study_id