NCT06249737

Brief Summary

Post-stroke rehabilitation of the upper extremity is a challenge in neurorehabilitation. Selective training of different degrees of freedom (training of specific monoarticular movements and in one plane of movement of the upper extremity) to achieve true recovery could be a good approach. However, it is not known how the training should be structured to avoid interference between the different movements trained, hindering the motor learning process during neurorehabilitation. This research aims to determine the effect on performance and kinematic control of a selective movement control task during one- or three-days training of 2 different degrees of freedom, close or distant in cortical representation, of the upper extremity in people with early subacute and chronic phase of stroke. The hypothesis is that in the upper extremity of subacute or chronic phase stroke survivors, learning 1 target DoF is interfered by training another DoF of the same joint. In contrast, learning 1 DoF from a different, distant joint does not interfere with learning the target DoF in a training session. Likewise, this interference is diminished in multiple training sessions. On the other hand, in early post-stroke phase, within the first 5 weeks, the gain in kinematic control of each controlled DoF is greater than in later post-stroke phases (between 9 to 12 weeks of evolution or chronic phase). An experimental design of 4 days of training, of approximately 60 minutes per day, will be carried out in people who are within the first 3 months after a stroke or in a chronic stage. There will be 3 intervention groups that will train the shoulder flexion movement of the paretic upper extremity and another movement, which can be of the same affected upper extremity or another of the contralateral lower extremity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

January 31, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

stroke recoverymotor learningupper extremity recoverylearning interference

Outcome Measures

Primary Outcomes (2)

  • 1 day performance changes

    Based on the expected trajectory and the actual trajectory of the videogame, the difference between these trajectories will be calculated to compare the changes of each trained DoF between the performance made at the beginning of one day of training, at the end of that same day and between the second day (retention test).

    day 2

  • 3 days performance changes

    Based on the expected trajectory and the actual trajectory of the videogame, the difference between these trajectories will be calculated to compare the changes of each trained DoF t the beginning of the first day of training andafter completing the four days of training.

    day 4

Secondary Outcomes (2)

  • 1 day smoothness changes

    day 2

  • 3 days smoothness changes

    day 4

Study Arms (3)

Control Group

EXPERIMENTAL

This group will train the DoF target (shoulder flexo-extension) and DoF dorsi-ankle flexion of the contralateral lower extremity.

Behavioral: Training

Proximal Interference Group

EXPERIMENTAL

This group will train the DoF target and shoulder abduction-adduction DoF.

Behavioral: Training

Distal Interference Group

EXPERIMENTAL

This group will train the DoF Tf and the wrist flexion-extension DoF.

Behavioral: Training

Interventions

TrainingBEHAVIORAL

Each participan will train the kinematic control of each degree of freedom, according to each arm, playing a videogame using an inertial sensor.

Control GroupDistal Interference GroupProximal Interference Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke diagnosis
  • Muscular strength according to the MRC scale of 2 or more in the shoulder flexor, shoulder abductor and wrist extensor muscles.

You may not qualify if:

  • Presence of another neurological or musculoskeletal disease that affects the mobility of the paretic upper extremity
  • Inability to follow instructions
  • Spasticity graded as 3 or more on the Modified Ashworth scale of flexor muscles of the upper extremity
  • Signs of cerebellar damage such as the presence of ataxia or dysmetria in the upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitat de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Unitat de dany Cerebral Adquirit

Valencia, 46014, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Trinidad Bruna-Melo, MSc

    Universitat de Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Trinidad Bruna-Melo, MSc

CONTACT

María Luz Sánchez-Sánchez, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: There will be 3 intervention groups where they will train the movement of different DoF of the affected upper extremity (the DoF target and other DoF of the shoulder or wrist) or the DoF target and other DoF of the contralateral lower extremity (to maintain the practice dose among all groups)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D, PT

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

January 22, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

for now, there is no plan to make IPD available to other researchers

Locations